QA Facility Contractors (2) (233311) Northern MA

Engineering Services | Healthcare IT | Life Sciences & Technology

Start Date: ASAP

Duration: 6 Months

Location: Northern MA

Description: The client is looking for QA Contractor who can come onsite and drive the project. They are expecting this person to have experience with room release, facility, and equipment qualification. The perfect candidate has experience within a clinical manufacturing environment.


• 7-10 years’ experience within biotech companies

Support Facility start-up in MTC-S (2nd floor and 1st floor) and MTC-N (GMP-P):

• Room qualification, room release, equipment and utilities qualification support

• Types of equipment: TFF, Skids, Fermenters

• SOPs updates, revisions and/or creation

• MBRs updates, revisions and/or creation

• VPMs updates, revisions and/or creation

• POL updates for phase appropriate raw material manufacturing

• SOP updates for phase appropriate raw material manufacturing

• MBRs for phase appropriate raw material manufacturing

• Cell Bank CTU Support

• CTU maintenance

• Process map for cell bank support

• Quality support of Cell Bank CTU for enable production or receiving of cell banks

About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date

Apply Now