Principal Sterility Assurance & Contamination Control Specialist
Rose International · Berkeley, CA · 1 mo ago
Project ManagementFull-time
We need to output HTML fragment with sections for headings where content exists. Must not repeat job title. Must not include Job ID etc. Must include sections only if real specific content.
We have:
- About the role? Not explicitly but we have Summary. Could treat as About the role? The instruction says use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can choose headings that match content.
We have Summary paragraph: "Seeking an experienced Principal Sterility Assurance & Contamination Control Specialist to support the Berkeley site's Sterility Assurance and Contamination Control Program..." That's like About the role.
We have Responsibilities list.
We have Required Qualifications (maybe Requirements). Also Preferred Qualifications.
We have Must Have Skills/Attributes (list). Also Experience Desired (list). Could combine under Requirements or Skills.
We have Pay: Min Hourly Rate $53.00 Max $59.00. So we can include Pay section.
We have Schedule: Shift: Monday-Friday, 9:00am Start, 8-hour shifts. Work Model: Hybrid (details TBD). Since Work Model details TBD, we should not include Schedule if it's just TBD? The schedule is given: Monday-Friday, 9:00am Start, 8-hour shifts. That's specific. So we can include Schedule.
We have Benefits: only says "For information and details on employment benefits offered with this position, please visit here." That's not specific benefit details, just a link. According to rule: never create Benefits section unless posting actually states them. It does not state specific benefits, just a pointer. So we should omit Benefits.
We have Pay: we have min/max hourly rate. That's specific, so include Pay.
We have Schedule: we have shift details. Include Schedule.
We have Location: Berkeley, CA, USA, 94710. Could be part of About the role or maybe a short p. Not a heading.
We have Employment Type: Temporary FT/PT: Full-Time. Estimated Duration 12 months. Could be included in About the role or maybe a separate section? Not in list of headings; we could put in About the role paragraph.
We must not include Job ID etc.
We must remove boilerplate: EEO, E-Verify, etc.
We must preserve all substantive information.
Let's extract content:
About the role / Summary:
"Seeking an experienced Principal Sterility Assurance & Contamination Control Specialist to support the Berkeley site's Sterility Assurance and Contamination Control Program. This senior individual contributor role will help drive the site's Contamination Control Strategy (CCS), program governance, risk management, metrics, action tracking and inspection readiness. The successful candidate will work across Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT/Technical Operations and Quality Risk Management to turn complex contamination-control risks into clear action plans, governance decisions and measurable improvements. This position does not have direct people-management responsibilities."
Also maybe include location, employment type, duration: "Job Location: Berkeley, CA, USA, 94710 Work Model: Hybrid Work Model Details: TBD at this time Shift: Monday-Friday, 9:00am Start, 8-hour shifts Employment Type: Temporary FT/PT: Full-Time Estimated Duration (In months): 12". We could incorporate location and schedule etc.
But schedule we already have separate.
We could include location in About the role paragraph.
Responsibilities list:
- Support implementation and continued maturity of the Berkeley site's Sterility Assurance and Contamination Control Program.
- Maintain the site CCS roadmap and action tracker, including owners, deadlines, dependencies, risk rankings, progress and escalation requirements.
- Prepare materials for Sterility Assurance governance meetings, including agendas, action logs, decision records, risk summaries and leadership updates.
- Partner with Quality Risk Management stakeholders to document, prioritize and escalate contamination-control risks.
- Integrate relevant data from Quality, QC Microbiology, Manufacturing, Engineering, Validation and Operations to support meaningful sterility assurance metrics.
- Develop periodic Sterility Assurance and Contamination Control health summaries covering high-risk gaps, overdue actions, contamination trends, CAPA effectiveness and inspection readiness.
- Support inspection-readiness activities involving CCS, contamination-control governance, risk-based decisions, CAPA tracking and program maturity.
- Develop and improve program tools such as charters, templates, decision trees, risk-review forms, dashboards and governance materials.
- Coordinate complex deliverables across multiple technical and quality functions while maintaining strong documentation and follow-through.
- Identify risks, barriers and overdue activities and ensure appropriate escalation and resolution.
Also note: "Drug screen & criminal background check will be required" - that's a requirement, maybe include in Requirements.
Requirements / Qualifications:
Required Education: Bachelor’s Degree in Microbiology, Biology, Biotechnology, Engineering, Pharmaceutical Sciences or a related scientific/technical field.
Required Qualifications:
- 8+ years of experience in pharmaceutical, biotechnology, biologics, sterile manufacturing, cell therapy, aseptic processing or a related GMP environment.
- Experience supporting sterility assurance, contamination control, quality systems, validation, QC Microbiology, manufacturing technical support or GMP program execution.
- Strong knowledge of GMP quality systems, deviations, CAPA, change control, risk management and inspection readiness.
- Demonstrated experience coordinating cross-functional programs, action trackers, dashboards, risk registers and leadership updates.
- Experience partnering with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT or Technical Operations.
- Strong technical writing, organization, facilitation and communication skills.
Preferred Qualifications:
- Experience developing, implementing or reviewing a Contamination Control Strategy.
- Experience with aseptic manufacturing, environmental monitoring, APS/media fills, cleaning and disinfection, microbial investigations or facility contamination control.
- Knowledge of EU GMP Annex 1, FDA aseptic processing guidance, ICH Q9/Q10, PDA technical reports and cleanroom standards.
- Experience supporting regulatory inspections, audit responses or inspection-readiness programs.
- Experience with FMEA, HACCP, fault-tree analysis, risk registers or other risk-based assessment methodologies.
Must Have Skills/Attributes:
- Environmental Reporting, GMP, Pharmaceutical, Quality Control (QC), Risk Analysis
Experience Desired:
- Aseptic manufacturing or sterile processing knowledge (8+ yrs)
- QC Microbiology and environmental monitoring exposure (8+ yrs)
- GMP quality systems and risk management (8+ yrs)
- CAPA, deviations and change control (8+ yrs)
- Inspection/audit readiness (8+ yrs)
These overlap with required qualifications; we can combine under Requirements or Skills.
We could have sections: About the role, Responsibilities, Requirements, Skills, Pay, Schedule.
We must not create sections with placeholder/filler. Ensure each heading has substantive content.
Pay: Min Hourly Rate $53.00 Max $59.00.
Schedule: Monday-Friday, 9:00am Start, 8-hour shifts. Hybrid work model (details TBD) - but TBD is placeholder; we should not include Work Model details if TBD. However schedule is specific; we can still include Schedule with the shift info. Hybrid work model details TBD is placeholder; we could omit that detail or just note "Hybrid". The rule: never emit a heading followed by filler/placeholder text (e.g., "commensurate with experience", "not specified", "N/A", "varies", "TBD"). So we should not include "Work Model Details: TBD". But we can still mention Hybrid as part of schedule? Might be okay if we just say "Hybrid". However the posting says "Work Model: Hybrid Work Model Details: TBD at this time". So we have Hybrid but details TBD. We could include "Hybrid" as part of schedule but not mention TBD. Might be acceptable.
Better to include Schedule section with shift details only, and maybe note Hybrid in About the role.
Let's craft HTML.
We'll output:
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can choose headings that match content.
We have Summary paragraph: "Seeking an experienced Principal Sterility Assurance & Contamination Control Specialist to support the Berkeley site's Sterility Assurance and Contamination Control Program..." That's like About the role.
We have Responsibilities list.
We have Required Qualifications (maybe Requirements). Also Preferred Qualifications.
We have Must Have Skills/Attributes (list). Also Experience Desired (list). Could combine under Requirements or Skills.
We have Pay: Min Hourly Rate $53.00 Max $59.00. So we can include Pay section.
We have Schedule: Shift: Monday-Friday, 9:00am Start, 8-hour shifts. Work Model: Hybrid (details TBD). Since Work Model details TBD, we should not include Schedule if it's just TBD? The schedule is given: Monday-Friday, 9:00am Start, 8-hour shifts. That's specific. So we can include Schedule.
We have Benefits: only says "For information and details on employment benefits offered with this position, please visit here." That's not specific benefit details, just a link. According to rule: never create Benefits section unless posting actually states them. It does not state specific benefits, just a pointer. So we should omit Benefits.
We have Pay: we have min/max hourly rate. That's specific, so include Pay.
We have Schedule: we have shift details. Include Schedule.
We have Location: Berkeley, CA, USA, 94710. Could be part of About the role or maybe a short p. Not a heading.
We have Employment Type: Temporary FT/PT: Full-Time. Estimated Duration 12 months. Could be included in About the role or maybe a separate section? Not in list of headings; we could put in About the role paragraph.
We must not include Job ID etc.
We must remove boilerplate: EEO, E-Verify, etc.
We must preserve all substantive information.
Let's extract content:
About the role / Summary:
"Seeking an experienced Principal Sterility Assurance & Contamination Control Specialist to support the Berkeley site's Sterility Assurance and Contamination Control Program. This senior individual contributor role will help drive the site's Contamination Control Strategy (CCS), program governance, risk management, metrics, action tracking and inspection readiness. The successful candidate will work across Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT/Technical Operations and Quality Risk Management to turn complex contamination-control risks into clear action plans, governance decisions and measurable improvements. This position does not have direct people-management responsibilities."
Also maybe include location, employment type, duration: "Job Location: Berkeley, CA, USA, 94710 Work Model: Hybrid Work Model Details: TBD at this time Shift: Monday-Friday, 9:00am Start, 8-hour shifts Employment Type: Temporary FT/PT: Full-Time Estimated Duration (In months): 12". We could incorporate location and schedule etc.
But schedule we already have separate.
We could include location in About the role paragraph.
Responsibilities list:
- Support implementation and continued maturity of the Berkeley site's Sterility Assurance and Contamination Control Program.
- Maintain the site CCS roadmap and action tracker, including owners, deadlines, dependencies, risk rankings, progress and escalation requirements.
- Prepare materials for Sterility Assurance governance meetings, including agendas, action logs, decision records, risk summaries and leadership updates.
- Partner with Quality Risk Management stakeholders to document, prioritize and escalate contamination-control risks.
- Integrate relevant data from Quality, QC Microbiology, Manufacturing, Engineering, Validation and Operations to support meaningful sterility assurance metrics.
- Develop periodic Sterility Assurance and Contamination Control health summaries covering high-risk gaps, overdue actions, contamination trends, CAPA effectiveness and inspection readiness.
- Support inspection-readiness activities involving CCS, contamination-control governance, risk-based decisions, CAPA tracking and program maturity.
- Develop and improve program tools such as charters, templates, decision trees, risk-review forms, dashboards and governance materials.
- Coordinate complex deliverables across multiple technical and quality functions while maintaining strong documentation and follow-through.
- Identify risks, barriers and overdue activities and ensure appropriate escalation and resolution.
Also note: "Drug screen & criminal background check will be required" - that's a requirement, maybe include in Requirements.
Requirements / Qualifications:
Required Education: Bachelor’s Degree in Microbiology, Biology, Biotechnology, Engineering, Pharmaceutical Sciences or a related scientific/technical field.
Required Qualifications:
- 8+ years of experience in pharmaceutical, biotechnology, biologics, sterile manufacturing, cell therapy, aseptic processing or a related GMP environment.
- Experience supporting sterility assurance, contamination control, quality systems, validation, QC Microbiology, manufacturing technical support or GMP program execution.
- Strong knowledge of GMP quality systems, deviations, CAPA, change control, risk management and inspection readiness.
- Demonstrated experience coordinating cross-functional programs, action trackers, dashboards, risk registers and leadership updates.
- Experience partnering with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT or Technical Operations.
- Strong technical writing, organization, facilitation and communication skills.
Preferred Qualifications:
- Experience developing, implementing or reviewing a Contamination Control Strategy.
- Experience with aseptic manufacturing, environmental monitoring, APS/media fills, cleaning and disinfection, microbial investigations or facility contamination control.
- Knowledge of EU GMP Annex 1, FDA aseptic processing guidance, ICH Q9/Q10, PDA technical reports and cleanroom standards.
- Experience supporting regulatory inspections, audit responses or inspection-readiness programs.
- Experience with FMEA, HACCP, fault-tree analysis, risk registers or other risk-based assessment methodologies.
Must Have Skills/Attributes:
- Environmental Reporting, GMP, Pharmaceutical, Quality Control (QC), Risk Analysis
Experience Desired:
- Aseptic manufacturing or sterile processing knowledge (8+ yrs)
- QC Microbiology and environmental monitoring exposure (8+ yrs)
- GMP quality systems and risk management (8+ yrs)
- CAPA, deviations and change control (8+ yrs)
- Inspection/audit readiness (8+ yrs)
These overlap with required qualifications; we can combine under Requirements or Skills.
We could have sections: About the role, Responsibilities, Requirements, Skills, Pay, Schedule.
We must not create sections with placeholder/filler. Ensure each heading has substantive content.
Pay: Min Hourly Rate $53.00 Max $59.00.
Schedule: Monday-Friday, 9:00am Start, 8-hour shifts. Hybrid work model (details TBD) - but TBD is placeholder; we should not include Work Model details if TBD. However schedule is specific; we can still include Schedule with the shift info. Hybrid work model details TBD is placeholder; we could omit that detail or just note "Hybrid". The rule: never emit a heading followed by filler/placeholder text (e.g., "commensurate with experience", "not specified", "N/A", "varies", "TBD"). So we should not include "Work Model Details: TBD". But we can still mention Hybrid as part of schedule? Might be okay if we just say "Hybrid". However the posting says "Work Model: Hybrid Work Model Details: TBD at this time". So we have Hybrid but details TBD. We could include "Hybrid" as part of schedule but not mention TBD. Might be acceptable.
Better to include Schedule section with shift details only, and maybe note Hybrid in About the role.
Let's craft HTML.
We'll output:
About the role
Seeking an experienced Principal Sterility Assurance & Contamination Control Specialist to support the Berkeley site's Sterility Assurance and Contamination Control Program. This senior individual contributor role will help drive the site's Contamination Control Strategy (CCS), program governance, risk management, metrics, action tracking and inspection readiness. The successful candidate will work across Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT/Technical Operations and Quality Risk Management to turn complex contamination-control risks into clear action plans, governance decisions and measurable improvements. This position does not have direct people-management responsibilities. The role is based in Berkeley, CA (94710) and is a temporary full‑time position with an estimated duration of 12 months.
Responsibilities
- Support implementation and continued maturity of the Berkeley site's Sterility Assurance and Contamination Control Program.
- Maintain the site CCS roadmap and action tracker, including owners, deadlines, dependencies, risk rankings, progress and escalation requirements.
- Prepare materials for Sterility Assurance governance meetings, including agendas, action logs, decision records, risk summaries and leadership updates.
- Partner with Quality Risk Management stakeholders to document, prioritize and escalate contamination-control risks.
- Integrate relevant data from Quality, QC Microbiology, Manufacturing, Engineering, Validation and Operations to support meaningful sterility assurance metrics.
- Develop periodic Sterility Assurance and Contamination Control health summaries covering high-risk gaps, overdue actions, contamination trends, CAPA effectiveness and inspection readiness.
- Support inspection-readiness activities involving CCS, contamination-control governance, risk-based decisions, CAPA tracking and program maturity.
- Develop and improve program tools such as charters, templates, decision trees, risk-review forms, dashboards and governance materials.
- Coordinate complex deliverables across multiple technical and quality functions while maintaining strong documentation and follow-through.
- Identify risks, barriers and overdue activities and ensure appropriate escalation and resolution.
Requirements
- Bachelor’s degree in Microbiology, Biology, Biotechnology, Engineering, Pharmaceutical Sciences or a related scientific/technical field.
- 8+ years of experience in pharmaceutical, biotechnology, biologics, sterile manufacturing, cell therapy, aseptic processing or a related GMP environment.
- Experience supporting sterility assurance, contamination control, quality systems, validation, QC Microbiology, manufacturing technical support or GMP program execution.
- Strong knowledge of GMP quality systems, deviations, CAPA, change control, risk management and inspection readiness.
- Demonstrated experience coordinating cross-functional programs, action trackers, dashboards, risk registers and leadership updates.
- Experience partnering with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT or Technical Operations.
- Strong technical writing, organization, facilitation and communication skills.
Skills
- Environmental Reporting
- GMP
- Pharmaceutical
- Quality Control (QC)
- Risk Analysis
- Aseptic manufacturing or sterile processing knowledge (8+ yrs)
- QC Microbiology and environmental monitoring exposure (8+ yrs)
- GMP quality systems and risk management (8+ yrs)
- CAPA, deviations and change control (8+ yrs)
- Inspection/audit readiness (8+ yrs)
Pay
Min Hourly Rate: $53.00 – Max Hourly Rate: $59.00
Schedule
Monday‑Friday, 9:00 am start, 8‑hour shifts (Hybrid work model)
We must not include any extra sections like Benefits. Ensure no boilerplate. Check