Scientist II, QC Microbiology

job summary:

• The Scientist II QC Microbiology serves as senior technical subject matter expert responsible for overseeing microbiological testing programs supporting GMP operations. This role provides technical leadership across QC Microbiology and Manufacturing by ensuring effective microbiological testing, mentoring laboratory staff, supporting quality systems and delivering aseptic technique training to maintain compliance with GMP and contamination control requirements.

location: Westborough, Massachusetts
job type: Contract
salary: $35.00 - 38.84 per hour
work hours: 9 to 5
education: Bachelors


responsibilities:

• Serve as subject matter expert for microbiological testing programs including environmental monitoring, sterility, endotoxin, mycoplasma, microbial identification, and contamination control.
• Support QC Microbiology Senior Manager in oversight of laboratory operations, technical initiatives, and microbiological program execution.
• Develop and deliver aseptic technique and contamination control training for manufacturing and QC personnel to maintain compliance with GMP and cleanroom practices.
• Track and support quality system activities including deviations, investigations, CAPAs, Change Control and trending associated with QC microbiology operations.
• Review and approve microbiological data, protocols, quarterly reports , SOPs and other technical documentation.
• Lead data trending and interpretation of environmental monitoring and microbiological data to identify risks and support contamination control strategy.
• Provide technical leadership and mentorship to microbiologists and junior scientist within QC microbiology laboratory.
• Author and review SOPs, protocols, validation reports, investigation reports and technical documents in accordance with GMP requirements.
• Lead or support method qualification, validation, and technology implementation for microbiological assays.
• Collaborate cross-functionally with Manufacturing, QA , Facilities and other teams to support manufacturing operations and process improvements.
• Support regulatory inspections, audits and responses by providing technical justification and documentation.

qualifications:

• BS degree in Biology/Microbiology with 10+ years or M.S. with 6+ years of relevant experience in a GMP QC microbiology laboratory.
• Demonstrated advanced expertise in microbiological testing including environmental monitoring, bioburden, endotoxin, sterility, mycoplasma and microbial identification.
• Experience supporting aseptic manufacturing environments and cleanroom operations.
• Demonstrated experience mentoring laboratory staff and providing technical training.
• Strong knowledge of cGMP regulations and microbiological control strategies.
• Excellent technical writing and communication skills.
• Strong interpersonal skills, highly collaborative within a multi-disciplinary team and contributes to a supportive and positive work environment.
• This role is scheduled to work during day shift (8 am to 5 pm) Monday to Friday.
• Flexibility to work weekend hours may be required to support GMP Operations.

skills: Microbiology, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Quality Control (QC)


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.