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QC Microbiology Lead (cGMP – Pharmaceutical) JD819683

JD819683

DPS is looking for an accomplished Quality Control/Microbiologist resource to support a biopharma client in the Boston, MA area. This individual will lead and support EM sampling of cleanrooms, utilities and fill operations.

Category:
Engineer Microbiology & Biotechnology
Location:
Massachusetts
Years of Experience Req.:
8+
Date Posted:
15/06/2019
Days Remaining:
18
Employment Type:
Full-time
Education Level Req.:
Bachelors

QC Microbiology Lead (cGMP – Pharmaceutical)      JD819683

Boston, MA area

 

Summary:

 

DPS is looking for an accomplished Quality Control/Microbiologist resource to support a biopharma client in the Boston, MA area. This individual will lead and support EM sampling of cleanrooms, utilities and fill operations. 

 

Job Responsibilities:

  • Oversee the overall Quality Control Microbiology laboratory strategy and operation, with a concentrated focus on facility utilities, environmental classification and control design, program design for Microbiology laboratory equipment, and facility qualification/control.
  • Assist the Aseptic Gowning and Training Programs as well as oversee media fill testing and reporting.
  • Maintain a robust Environmental Monitoring program that meet US/EU and other applicable regulatory requirements.
  • Lead laboratory staff, set goals and expectations, and maintain efficient utiliz361382.047559ation of resources.
  • Author and approve documents required for regulatory submissions.
  • Develop, author, implement and enforce Microbiology laboratory procedures and policies.
  • Provide presentations, explain laboratory qualification and operations, and defend testing results during FDA and other inspections.

 

Qualifications:

  • Bachelors/Masters of Science in microbiology or related discipline.
  • 8+ years of experience in a cGMP microbiology testing laboratory environment, with strong knowledge of regulatory guidelines as related to microbiology issues, aseptic processing, and bio-safety.
  • Experience in setting up GMP laboratory, implementation of LIMS and MODA is recommended.
  • Working knowledge of GMP and good documentation practice (GDP) as it relates to the QC laboratory is desirable.
  • Detail oriented and the ability to communicate effectively, proactively and professionally to clients and members of the management team.
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