Quality Control Analyst
Pay: $32.73/hr
Hours: 8:00 am to 5:00 pm, Mon - Fri
Location: Onsite Cambridge MA 02139
Duration: 1 Year

Position Description:

• The Analyst, Cell Therapies QC Microbiology is responsible for the performance of microbiological related activities at the Cell Therapies Manufacturing Facility in Cambridge.
• This position is responsible to assist in all microbiological related activities needed in the in-house GMP cell therapies production of investigational new drugs from development, transfer, (re-)qualification, (re-)validation to routine performance activities.

Primary responsibilities:

• Perform environmental monitoring (viable particle monitoring -air, settle plates, contact plates as well as non-viable particulate monitoring) of the Cell Therapies Manufacturing Facility in Cambridge.
• Perform plate reading and Data entry/verification of the test results.
• Perform RODI sampling.
• Responsible for shipping and tracking samples and test results.
• Participate in environmental monitoring performance (re-)qualifications and aseptic process (re-)validations.
• Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
• Keep the Microbiology lab clean, safe and tidy all the time.

Secondary responsibilities:

• Perform gowning qualifications for personnel needing access to the internal GMP facility.
• Perform growth promotion tests.
• Assist in release testing (Sterility, Endotoxin and Mycoplasma) related to microbiology as needed to support the manufacturing of investigational new cell therapy drug products manufactured in the internal GMP facility in Cambridge.
• Assist in the EM investigations per SOP.
• Other Micro support as needed.
• Bachelor’s Degree in Microbiology or another relevant field

Minimum of 0-1 years’ experience in the bio/pharmaceutical industry
Minimum of 0-1 years’ experience in GMP QC Microbiology laboratory
Experience in performing environmental monitoring in GMP cleanrooms (Grade A-C)
Experience in gowning qualification and aseptic techniques
Microbiology knowledge and practical experience of microbiology testing
Excellent organizational, communication, and interpersonal skills
Ability to adapt to changing priorities
In general, the position requires a standing for extended periods of time in the microbiology laboratory and gowned up in the cleanrooms.

This role supports pharmaceutical production operations therefore the work environment includes exposure to production and cell processing facilities, packaging, component printing and analytical laboratories (this list is not exhaustive).

Benefits (employee contribution):
 Health insurance
 Health savings account
 Dental insurance
 Vision insurance
 Flexible spending accounts
 Life insurance
 Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Type: Contract

Pay: $32.73 per hour

Benefits:

• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Retirement plan
• Vision insurance

Schedule:

• Monday to Friday

Work Location: One location

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