Quality Control Microbiologist

We need to output HTML fragment with sections: About the role, Responsibilities, Requirements (or Skills, Qualifications), Benefits, Pay, Schedule. Must only include sections with real content. The posting includes Pay And Benefits with pay range and benefits list. Also Work Environment, Job Type & Location, etc. We need to decide which sections to include. We have to use

for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must not repeat job title as heading. Must not put Job ID etc. We must preserve all substantive info, no invented details. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions. Also remove "About Actalent", equal opportunity etc. Also remove "Application Deadline". Also remove "Work Environment"? It's substantive but not a required heading; we could incorporate into About the role or maybe a separate section? The instruction says we can include sections only when posting has real, specific content for it. We can choose to include About the role (summary), Responsibilities, Skills (or Qualifications), Benefits, Pay. Schedule not present, so omit. We need to decide what goes into each. About the role: likely the first paragraph after Job Description: "The Quality Control Microbiologist will support a new commercial cell therapy production center by performing microbiological testing and environmental monitoring to ensure product quality and patient safety. This role focuses on product testing, utility testing, and comprehensive environmental monitoring within a cutting-edge GMP cell therapy manufacturing environment advancing innovative treatments for autoimmune diseases." That's good. Responsibilities: list of duties. We need to extract bullet points from the responsibilities paragraph. The responsibilities section is a long paragraph with many sentences separated by periods. We should convert each distinct duty into

. Must preserve all substantive info; not invent. We need to parse responsibilities: "Perform environmental and utility monitoring and sampling as a primary function, including routine collection of facility and utility system samples in accordance with SOPs." "Conduct routine and non-routine inspection of media fill samples (AOQ/APV), and perform collection and testing of media, final product, validation-related, and critical utility samples following established procedures." "Receive, quarantine, and store purchased microbiological media pending laboratory release, ensuring proper documentation and compliance with quality standards." "Monitor biohazardous waste and coordinate its safe removal with qualified safety personnel in alignment with regulatory and internal safety requirements." "Participate in validation activities and support commercial and developmental manufacturing operations by providing microbiology and environmental monitoring expertise." "Review and issue Environmental Notifications based on raw data and validated electronic data acquisition systems, ensuring accurate interpretation and timely communication of results." "Represent Quality Control for microbiology and environmental monitoring in site meetings, providing technical input and supporting cross-functional decision-making." "Support testing of solid oral dosage forms, packaging component testing, raw material testing, and sterile product testing as needed." "Troubleshoot standard instrumentation and test methods, resolving technical issues and supporting continuous improvement of laboratory processes." "Perform activities in support of final product release testing, including assays for endotoxin, sterility, and particle isolation, as well as raw material testing such as media growth promotion." "Conduct environmental monitoring activities including surface viable air sampling, non-viable air monitoring, and personnel monitoring in controlled areas and cleanrooms." "Perform bioburden testing of water and product, and monitor viable and non-viable particles and moisture levels in compressed gases and air systems." "Write deviations and standard operating procedures (SOPs), and contribute to change control and validation documentation to ensure compliance with ICH, FDA, USP, and other regulatory requirements." "Provide technical training on environmental monitoring of facilities and utility systems, helping team members understand compliance requirements and the impact of their work on product quality." "Work both independently and as part of cross-functional project teams to support Phase 3 and BLA-related activities and contribute to building out the QC microbiology function as the site moves toward commercialization." That's all responsibilities. Now Skills/Essential Skills and Additional Skills & Qualifications. We need to decide which heading to use: maybe "Skills" or "Qualifications". The instruction says we can use headings like Skills, Qualifications, Requirements. We need to include only if posting has real specific content. We have both Essential Skills and Additional Skills & Qualifications. We could combine into a single "Skills" section, or separate "Requirements" and "Additional Skills". But better to have one "Skills" section that lists all skills. However we must not lose info. We could create two sections: "Requirements" for essential skills (minimum) and "Additional Skills & Qualifications" for extra. But the instruction says prefer a few substantive sections over many thin ones. So maybe combine into one "Skills" section that includes both essential and additional. But we need to follow the allowed headings: Skills is allowed. So we can make a

Skills

and list all skills as

• . Must preserve all details. Let's extract essential skills list: - At least 2 years of relevant experience in microbiology, quality control, or a related laboratory discipline. - Associate’s or Bachelor’s degree in microbiology, biology, chemistry, or a related scientific field. - Hands-on quality control microbiology experience, including environmental monitoring and utility testing in a GMP setting. - Practical experience with environmental monitoring in cleanrooms, including air sampling, surface sampling, and personnel monitoring. - Experience with aseptic technique and working in controlled or cleanroom environments. - Knowledge of general microbiology techniques such as gram staining and plate streaking. - Experience with sterility testing, bioburden testing, and media growth promotion testing. - Understanding of compliance documentation and regulations, including GMP, GLP, and relevant regulatory standards. - Ability to perform gas and water testing and interpret microbiological data for utilities. - Capability to troubleshoot standard laboratory instrumentation and test methods. - Strong verbal, written, and interpersonal communication skills to effectively collaborate with cross-functional teams. - Ability to work effectively in a team environment while also managing individual responsibilities and projects. Additional Skills & Qualifications list: - Prior experience in the biopharmaceutical or pharmaceutical industry, particularly in a GMP manufacturing or QC laboratory setting. - Previous laboratory experience performing microbiological assays and environmental monitoring. - Basic knowledge of current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) applied on a daily basis. - Knowledge of USP and other regulatory requirements relevant to microbiology and environmental monitoring. - Familiarity with ICH and FDA regulations and an understanding of how they impact QC processes and product quality. - Knowledge of HPLC and UPLC systems and their role in analytical testing within a QC environment. - Proficiency in Microsoft Office applications for data analysis, reporting, and documentation. - Experience with MODAL/LIMS or similar laboratory information management systems for sample tracking and data management. - Technical training or experience in environmental monitoring of facilities and utility systems. - Ability to write deviations, SOPs, and other quality documents at a high level, contributing to validation activities and continuous improvement. - Demonstrated ability to train and educate colleagues on structured processes, change control, and compliance practices. - Comfort working in a fast-paced, rapidly growing biotech environment and contributing to Phase 3 and BLA/commercial readiness activities. - Motivation to develop new skills and progress into future roles as the QC and manufacturing teams expand toward commercialization. We can combine. Now Benefits and Pay: The posting includes "Pay And Benefits" with pay range and benefits list. We need separate sections for Pay and Benefits? The instruction allows headings Pay and Benefits. We should include both if content present. Pay: "$34.00 - $40.00/hr." plus note about individual compensation depending on factors. 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 should preserve all. Schedule: Not present, so omit. We also have Work Environment and Job Type & Location. Could incorporate into About the role or maybe a separate section like "Work Environment". But not in allowed headings list? Allowed headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Work Environment not allowed. So we should fold that info into About the role or maybe Skills? Better to incorporate into About the role: mention that role is based in both office space and GMP manufacturing suites, controlled cleanroom environments, etc. Also Job Type & Location: Contract position based out of Frederick, MD. Could also be in About the role. Thus About the role can be expanded to include those details. We must not repeat job title. So About the role heading

  About the role

  then a

  with the description. Now we need to output only HTML fragment, no /, no markdown fences. Let's craft:

  About the role

  The Quality Control Microbiologist will support a new commercial cell therapy production center by performing microbiological testing and environmental monitoring to ensure product quality and patient safety. This role focuses on product testing, utility testing, and comprehensive environmental monitoring within a cutting-edge GMP cell therapy manufacturing environment advancing innovative treatments for autoimmune diseases. The position is a contract role based in Frederick, MD, working in both office space and GMP manufacturing suites, including controlled cleanroom environments that require strict aseptic technique, environmental monitoring protocols, and compliance with GMP and GLP standards.

  Now Responsibilities:

  Responsibilities

  • Perform environmental and utility monitoring and sampling as a primary function, including routine collection of facility and utility system samples in accordance with SOPs.
  • Conduct routine and non-routine inspection of media fill samples (AOQ/APV), and perform collection and testing of media, final product, validation-related, and critical utility samples following established procedures.
  • Receive, quarantine, and store purchased microbiological media pending laboratory release, ensuring proper documentation and compliance with quality standards.
  • Monitor biohazardous waste and coordinate its safe removal with qualified safety personnel in alignment with regulatory and internal safety requirements.
  • Participate in validation activities and support commercial and developmental manufacturing operations by providing microbiology and environmental monitoring expertise.
  • Review and issue Environmental Notifications based on raw data and validated electronic data acquisition systems, ensuring accurate interpretation and timely communication of results.
  • Represent Quality Control for microbiology and environmental monitoring in site meetings, providing technical input and supporting cross-functional decision-making.
  • Support testing of solid oral dosage forms, packaging component testing, raw material testing, and sterile product testing as needed.
  • Troubleshoot standard instrumentation and test methods, resolving technical issues and supporting continuous improvement of laboratory processes.
  • Perform activities in support of final product release testing, including assays for endotoxin, sterility, and particle isolation, as well as raw material testing such as media growth promotion.
  • Conduct environmental monitoring activities including surface viable air sampling, non-viable air monitoring, and personnel monitoring in controlled areas and cleanrooms.
  • Perform bioburden testing of water and product, and monitor viable and non-viable particles and moisture levels in compressed gases and air systems.
  • Write deviations and standard operating procedures (SOPs), and contribute to change control and validation documentation to ensure compliance with ICH, FDA, USP, and other regulatory requirements.
  • Provide technical training on environmental monitoring of facilities and utility systems, helping team members understand compliance requirements and the impact of their work on product quality.
  • Work both independently and as part of cross-functional project teams to support Phase 3 and BLA-related activities and contribute to building out the QC microbiology function as the site moves toward commercialization.
  Now Skills:

  Skills

  • At least 2 years of relevant experience in microbiology