Medical Device Scientist
Actalent · Hopkins, MN · 1 mo ago
On-siteAnalyst$25–$35/hrContract
We need to output HTML fragment only, with sections as per rules. Use for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. However we only include sections that have real specific content. The posting includes: Responsibilities (list), Essential Skills (list), Additional Skills & Qualifications (list), Work Environment (prose), Job Type & Location (maybe location but not needed as heading?), Pay And Benefits (pay range and benefits list), Workplace Type (maybe schedule? Actually schedule not given; we have fully onsite position, but schedule not specified; we should not create Schedule section unless posting actually states schedule. It does not mention schedule/hours, so we omit Schedule. Benefits: we have list of benefits. Pay: we have pay range. So we can have sections: Responsibilities, Essential Skills (maybe as Skills), Additional Skills & Qualifications (maybe as Qualifications or Skills). The rules: Use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to map content to these headings. About the role: we have job description paragraph at start: "The Scientist will perform analytical testing..." That's about the role. So we can have About the role section with that paragraph.
Responsibilities: list of duties.
Requirements: maybe we can combine Essential Skills as requirements? But we have separate sections for Skills and Qualifications. The posting has Essential Skills (list) and Additional Skills & Qualifications (list). We could treat Essential Skills as Skills, Additional Skills & Qualifications as Qualifications. Or we could have Requirements as a combined list? But better to follow headings: Skills and Qualifications.
We also have Work Environment (maybe About the role? but we already used that). Could also be part of About the role. But we can add a section like Work Environment? Not in allowed headings list. The allowed headings are specified: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we must only use those headings. So we need to fit content into those.
Thus:
- About the role: include the job description paragraph (the first paragraph after Job Description) and maybe also Work Environment paragraph? The Work Environment paragraph describes the setting; could be part of About the role. We'll include it there.
- Responsibilities: list of duties.
- Requirements: maybe we can include Essential Skills as Requirements? But we also have Skills heading. The rules say we can use Skills heading for skill list. So we could put Essential Skills under Skills heading. Then Qualifications heading for Additional Skills & Qualifications. Requirements heading maybe for education/experience basics? The posting includes Bachelor’s degree, 1-3 years experience, etc. Those could be under Requirements. But we also have Skills heading for skill-specific items. Let's parse:
Essential Skills list includes:
- Bachelor’s degree in chemistry, biology, materials science, or a closely related scientific discipline.
- 1–3 years of hands-on laboratory experience in a GMP-regulated laboratory environment.
- Industry experience performing UV/Vis spectroscopy for analytical testing.
- Practical experience with filtration testing, including membrane filtration, particulate testing, and filter integrity testing.
- Experience using microscopy to identify and characterize particles and contaminants in samples.
- Familiarity with maintaining a lab notebook or working within an electronic lab notebook (ELN) system.
- Working knowledge of cGMP requirements and Good Documentation Practices (GDP) in a regulated laboratory setting.
- Ability to follow detailed SOPs and test methods accurately and consistently.
- Strong attention to detail and commitment to data integrity and regulatory compliance.
These are a mix of education/experience and skills. Could be considered Requirements. But we also have Additional Skills & Qualifications list with more items.
We could assign:
- Requirements: Bachelor’s degree, 1–3 years experience, maybe also familiarity with cGMP/GDP, ability to follow SOPs, attention to detail.
- Skills: UV/Vis spectroscopy experience, filtration testing experience, microscopy experience, ELN familiarity, etc.
- Qualifications: Additional Skills & Qualifications list (contract testing lab experience, HPLC/FTIR/particle sizing, method validation, CAPA, USP/EP/ICH guidelines, audit support, problem-solving).
But we need to avoid duplication and ensure we preserve all substantive information. Let's extract all bullet points.
From Essential Skills (I'll list each):
1. Bachelor’s degree in chemistry, biology, materials science, or a closely related scientific discipline.
2. 1–3 years of hands-on laboratory experience in a GMP-regulated laboratory environment.
3. Industry experience performing UV/Vis spectroscopy for analytical testing.
4. Practical experience with filtration testing, including membrane filtration, particulate testing, and filter integrity testing.
5. Experience using microscopy to identify and characterize particles and contaminants in samples.
6. Familiarity with maintaining a lab notebook or working within an electronic lab notebook (ELN) system.
7. Working knowledge of cGMP requirements and Good Documentation Practices (GDP) in a regulated laboratory setting.
8. Ability to follow detailed SOPs and test methods accurately and consistently.
9. Strong attention to detail and commitment to data integrity and regulatory compliance.
Additional Skills & Qualifications list:
- Experience working in a contract testing laboratory environment.
- Instrumentation experience with HPLC, FTIR, and particle sizing equipment.
- Exposure to method validation or technology transfer activities within a regulated setting.
- Prior experience authoring CAPA (Corrective and Preventive Action) investigations.
- Familiarity with USP, EP, and ICH guidelines and understanding of FDA regulatory expectations.
- Ability to support audits and contribute to continuous improvement initiatives in the laboratory.
- Strong problem-solving skills and ability to participate effectively in OOS, OOT, and deviation investigations.
Now Responsibilities list (from the posting):
- Perform analytical laboratory testing on client samples by following established standard operating procedures (SOPs) and approved test methods.
- Analyze samples using UV/Vis spectroscopy to generate accurate and reliable quantitative and qualitative data.
- Conduct filtration testing, including membrane filtration, particulate evaluations, and related filter integrity assessments.
- Use microscopy to examine and identify particles, contaminants, and key sample characteristics.
- Record and review laboratory data in compliance with cGMP and Good Documentation Practices (GDP), ensuring data integrity and traceability.
- Maintain accurate laboratory records and enter results into laboratory information management systems (LIMS) or electronic lab notebooks (ELN) when applicable.
- Ensure all testing activities align with FDA and other relevant regulatory requirements and internal quality standards.
- Prepare reagents, solutions, and standards needed for routine and specialized testing activities.
- Maintain, calibrate, and troubleshoot laboratory equipment to support consistent and reliable operation.
- Participate in investigations involving out-of-specification (OOS), out-of-trend (OOT) results, deviations, and other quality events.
- Assist with updating SOPs and supporting audits, inspections, and continuous improvement initiatives within the laboratory.
- Contribute to the ongoing expansion of testing services by supporting new methods, technologies, and process improvements as the laboratory grows.
Now About the role: The initial paragraph: "The Scientist will perform analytical testing on client samples using UV/Vis spectroscopy, filtration techniques, and microscopy in a regulated laboratory environment. This role focuses on generating high-quality data while ensuring all work complies with FDA regulations and cGMP standards. It is an excellent opportunity for professionals from pharmaceutical, medical device, biotech, contract testing, or other regulated laboratories who want to contribute to the expansion and build-out of a growing testing facility."
Also Work Environment paragraph: "The role is based in a brand-new contract testing laboratory that focuses on supporting pharmaceutical and medical device clients. The team is in an early growth phase and is adding key roles to help build out the business and expand testing services. You will work with modern analytical instrumentation and laboratory systems in a cGMP-compliant environment, collaborating closely with other scientists and quality-focused professionals. The setting offers the opportunity to influence laboratory processes and contribute to a culture of continuous improvement and scientific excellence."
We can combine these into About the role.
Pay And Benefits: Pay range: $25.00 - $35.00/hr. Benefits list: Medical, dental & vision; Critical Illness, Accident, and Hospital; 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available; Life Insurance (Voluntary Life & AD&D for the employee and dependents); Short and long-term disability; Health Spending Account (HSA); Transportation benefits; Employee Assistance Program; Time Off/Leave (PTO, Vacation or Sick Leave).
We need to output Benefits section with a
for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. However we only include sections that have real specific content. The posting includes: Responsibilities (list), Essential Skills (list), Additional Skills & Qualifications (list), Work Environment (prose), Job Type & Location (maybe location but not needed as heading?), Pay And Benefits (pay range and benefits list), Workplace Type (maybe schedule? Actually schedule not given; we have fully onsite position, but schedule not specified; we should not create Schedule section unless posting actually states schedule. It does not mention schedule/hours, so we omit Schedule. Benefits: we have list of benefits. Pay: we have pay range. So we can have sections: Responsibilities, Essential Skills (maybe as Skills), Additional Skills & Qualifications (maybe as Qualifications or Skills). The rules: Use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to map content to these headings. About the role: we have job description paragraph at start: "The Scientist will perform analytical testing..." That's about the role. So we can have About the role section with that paragraph.
Responsibilities: list of duties.
Requirements: maybe we can combine Essential Skills as requirements? But we have separate sections for Skills and Qualifications. The posting has Essential Skills (list) and Additional Skills & Qualifications (list). We could treat Essential Skills as Skills, Additional Skills & Qualifications as Qualifications. Or we could have Requirements as a combined list? But better to follow headings: Skills and Qualifications.
We also have Work Environment (maybe About the role? but we already used that). Could also be part of About the role. But we can add a section like Work Environment? Not in allowed headings list. The allowed headings are specified: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we must only use those headings. So we need to fit content into those.
Thus:
- About the role: include the job description paragraph (the first paragraph after Job Description) and maybe also Work Environment paragraph? The Work Environment paragraph describes the setting; could be part of About the role. We'll include it there.
- Responsibilities: list of duties.
- Requirements: maybe we can include Essential Skills as Requirements? But we also have Skills heading. The rules say we can use Skills heading for skill list. So we could put Essential Skills under Skills heading. Then Qualifications heading for Additional Skills & Qualifications. Requirements heading maybe for education/experience basics? The posting includes Bachelor’s degree, 1-3 years experience, etc. Those could be under Requirements. But we also have Skills heading for skill-specific items. Let's parse:
Essential Skills list includes:
- Bachelor’s degree in chemistry, biology, materials science, or a closely related scientific discipline.
- 1–3 years of hands-on laboratory experience in a GMP-regulated laboratory environment.
- Industry experience performing UV/Vis spectroscopy for analytical testing.
- Practical experience with filtration testing, including membrane filtration, particulate testing, and filter integrity testing.
- Experience using microscopy to identify and characterize particles and contaminants in samples.
- Familiarity with maintaining a lab notebook or working within an electronic lab notebook (ELN) system.
- Working knowledge of cGMP requirements and Good Documentation Practices (GDP) in a regulated laboratory setting.
- Ability to follow detailed SOPs and test methods accurately and consistently.
- Strong attention to detail and commitment to data integrity and regulatory compliance.
These are a mix of education/experience and skills. Could be considered Requirements. But we also have Additional Skills & Qualifications list with more items.
We could assign:
- Requirements: Bachelor’s degree, 1–3 years experience, maybe also familiarity with cGMP/GDP, ability to follow SOPs, attention to detail.
- Skills: UV/Vis spectroscopy experience, filtration testing experience, microscopy experience, ELN familiarity, etc.
- Qualifications: Additional Skills & Qualifications list (contract testing lab experience, HPLC/FTIR/particle sizing, method validation, CAPA, USP/EP/ICH guidelines, audit support, problem-solving).
But we need to avoid duplication and ensure we preserve all substantive information. Let's extract all bullet points.
From Essential Skills (I'll list each):
1. Bachelor’s degree in chemistry, biology, materials science, or a closely related scientific discipline.
2. 1–3 years of hands-on laboratory experience in a GMP-regulated laboratory environment.
3. Industry experience performing UV/Vis spectroscopy for analytical testing.
4. Practical experience with filtration testing, including membrane filtration, particulate testing, and filter integrity testing.
5. Experience using microscopy to identify and characterize particles and contaminants in samples.
6. Familiarity with maintaining a lab notebook or working within an electronic lab notebook (ELN) system.
7. Working knowledge of cGMP requirements and Good Documentation Practices (GDP) in a regulated laboratory setting.
8. Ability to follow detailed SOPs and test methods accurately and consistently.
9. Strong attention to detail and commitment to data integrity and regulatory compliance.
Additional Skills & Qualifications list:
- Experience working in a contract testing laboratory environment.
- Instrumentation experience with HPLC, FTIR, and particle sizing equipment.
- Exposure to method validation or technology transfer activities within a regulated setting.
- Prior experience authoring CAPA (Corrective and Preventive Action) investigations.
- Familiarity with USP, EP, and ICH guidelines and understanding of FDA regulatory expectations.
- Ability to support audits and contribute to continuous improvement initiatives in the laboratory.
- Strong problem-solving skills and ability to participate effectively in OOS, OOT, and deviation investigations.
Now Responsibilities list (from the posting):
- Perform analytical laboratory testing on client samples by following established standard operating procedures (SOPs) and approved test methods.
- Analyze samples using UV/Vis spectroscopy to generate accurate and reliable quantitative and qualitative data.
- Conduct filtration testing, including membrane filtration, particulate evaluations, and related filter integrity assessments.
- Use microscopy to examine and identify particles, contaminants, and key sample characteristics.
- Record and review laboratory data in compliance with cGMP and Good Documentation Practices (GDP), ensuring data integrity and traceability.
- Maintain accurate laboratory records and enter results into laboratory information management systems (LIMS) or electronic lab notebooks (ELN) when applicable.
- Ensure all testing activities align with FDA and other relevant regulatory requirements and internal quality standards.
- Prepare reagents, solutions, and standards needed for routine and specialized testing activities.
- Maintain, calibrate, and troubleshoot laboratory equipment to support consistent and reliable operation.
- Participate in investigations involving out-of-specification (OOS), out-of-trend (OOT) results, deviations, and other quality events.
- Assist with updating SOPs and supporting audits, inspections, and continuous improvement initiatives within the laboratory.
- Contribute to the ongoing expansion of testing services by supporting new methods, technologies, and process improvements as the laboratory grows.
Now About the role: The initial paragraph: "The Scientist will perform analytical testing on client samples using UV/Vis spectroscopy, filtration techniques, and microscopy in a regulated laboratory environment. This role focuses on generating high-quality data while ensuring all work complies with FDA regulations and cGMP standards. It is an excellent opportunity for professionals from pharmaceutical, medical device, biotech, contract testing, or other regulated laboratories who want to contribute to the expansion and build-out of a growing testing facility."
Also Work Environment paragraph: "The role is based in a brand-new contract testing laboratory that focuses on supporting pharmaceutical and medical device clients. The team is in an early growth phase and is adding key roles to help build out the business and expand testing services. You will work with modern analytical instrumentation and laboratory systems in a cGMP-compliant environment, collaborating closely with other scientists and quality-focused professionals. The setting offers the opportunity to influence laboratory processes and contribute to a culture of continuous improvement and scientific excellence."
We can combine these into About the role.
Pay And Benefits: Pay range: $25.00 - $35.00/hr. Benefits list: Medical, dental & vision; Critical Illness, Accident, and Hospital; 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available; Life Insurance (Voluntary Life & AD&D for the employee and dependents); Short and long-term disability; Health Spending Account (HSA); Transportation benefits; Employee Assistance Program; Time Off/Leave (PTO, Vacation or Sick Leave).
We need to output Benefits section with a - list.
Pay section: maybe just a
with the pay range.
Schedule: Not provided, so we omit Schedule section.
Now we need to output only HTML fragment, no /, no markdown.
We'll produce:
About the role
...combined paragraphs...
Responsibilities
- ...
...
Requirements
- Bachelor’s degree in chemistry, biology, materials science, or a closely related scientific discipline.
- 1–3 years of hands-on laboratory experience in a GMP-regulated laboratory environment.
- Working knowledge of cGMP requirements and Good Documentation Practices (GDP) in a regulated laboratory setting.
- Ability to follow detailed SOPs and test methods accurately and consistently.
- Strong attention to detail and commitment to data integrity and regulatory compliance.
Skills
- Industry experience performing UV/Vis spectroscopy for analytical testing.
- Practical experience with filtration testing, including membrane filtration, particulate testing, and filter integrity testing.
- Experience using microscopy to identify and characterize particles and contaminants in samples.
- Familiarity with maintaining a lab notebook or working within an electronic lab notebook (ELN) system.
Qualifications
- Experience working in a contract testing laboratory environment.
- Instrumentation experience with HPLC, FTIR, and particle sizing equipment.
- Exposure to method validation or technology transfer activities within a regulated setting.
- Prior experience authoring CAPA (Corrective and Preventive Action) investigations.
- Familiarity with USP, EP, and ICH guidelines and understanding of FDA regulatory expectations.
- Ability to support audits and contribute to continuous improvement initiatives in the laboratory.
- Strong problem-solving skills and ability to participate effectively in OOS, OOT, and deviation investigations.
Benefits
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
Pay
The pay range for this position is $25.00 - $35.00/hr.
We need to ensure we didn't miss any substantive info: Job Type & Location (Contract to Hire based out of Minnetonka, MN). That's location and job type. Should we include that? The rules say we can include sections only when posting has real specific content. We have no heading for Job Type or Location in allowed list. Could we put it under About the role? Possibly add a sentence about location and job type. The About the role section could include that info. Let's incorporate: "This is a Contract to Hire position based out of Minnetonka, MN." Also mention Workplace Type: fully onsite position in Minnetonka,MN. That's redundant. We
with the pay range. Schedule: Not provided, so we omit Schedule section. Now we need to output only HTML fragment, no /, no markdown. We'll produce:
About the role
...combined paragraphs...
Responsibilities
- ... ...
Requirements
- Bachelor’s degree in chemistry, biology, materials science, or a closely related scientific discipline.
- 1–3 years of hands-on laboratory experience in a GMP-regulated laboratory environment.
- Working knowledge of cGMP requirements and Good Documentation Practices (GDP) in a regulated laboratory setting.
- Ability to follow detailed SOPs and test methods accurately and consistently.
- Strong attention to detail and commitment to data integrity and regulatory compliance.
Skills
- Industry experience performing UV/Vis spectroscopy for analytical testing.
- Practical experience with filtration testing, including membrane filtration, particulate testing, and filter integrity testing.
- Experience using microscopy to identify and characterize particles and contaminants in samples.
- Familiarity with maintaining a lab notebook or working within an electronic lab notebook (ELN) system.
Qualifications
- Experience working in a contract testing laboratory environment.
- Instrumentation experience with HPLC, FTIR, and particle sizing equipment.
- Exposure to method validation or technology transfer activities within a regulated setting.
- Prior experience authoring CAPA (Corrective and Preventive Action) investigations.
- Familiarity with USP, EP, and ICH guidelines and understanding of FDA regulatory expectations.
- Ability to support audits and contribute to continuous improvement initiatives in the laboratory.
- Strong problem-solving skills and ability to participate effectively in OOS, OOT, and deviation investigations.
Benefits
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
Pay
The pay range for this position is $25.00 - $35.00/hr.
We need to ensure we didn't miss any substantive info: Job Type & Location (Contract to Hire based out of Minnetonka, MN). That's location and job type. Should we include that? The rules say we can include sections only when posting has real specific content. We have no heading for Job Type or Location in allowed list. Could we put it under About the role? Possibly add a sentence about location and job type. The About the role section could include that info. Let's incorporate: "This is a Contract to Hire position based out of Minnetonka, MN." Also mention Workplace Type: fully onsite position in Minnetonka,MN. That's redundant. We