NC: QA Manufacturing Specialist (CQV) (232651)

Life Sciences & Technology | Validation

Job Description:

Client in the midst of a construction expansion project and now at the stage of Commissioning and moving into Qualification soon. Looking for resources from a QA standpoint who can review and approve of URS, FAT, IQ OQ PQ procedures for manufacturing equipment, facilities, and utilities. C&Q document review is what we need from a QA perspective. NOT looking for lab folks or pilot plant folks, looking for folks coming from pharma / bio who have QA Manufacturing experience. QA oversight of validation/qualification activities, huge plus if they have capital project experience.
Prefer GMP Quality experience with biological drug substance or drug product. Work will also entail review of master batch records, SOPs and investigations.


Quality Assurance, Manufacturing, Review/Approval of Validation

Education Minimum Requirement:

• Bachelor’s and/or Master’s Degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline. Will consider Associate degree if they have 7+years of relevant experience.

Required Experience and Skills:

• With Bachelor’s Degree, at least 5 years of experience in the pharmaceutical industry or highly regulated industry.
• With Master’s degree, at least 3 years of experience in the pharmaceutical industry or highly regulated industry.
• Experience with review and approval of URS, FAT, IQ, OQ, PQ for manufacturing equipment, facilities and utilities..
• Strong contemporary knowledge of relevant current good manufacturing practices (cGMPs), regulations and current industry trends.
• Effective decision making, problem solving and communication skills. Ability to manage multiple priorities.
• Demonstrated ability to work in fast-paced, complex environments and escalate appropriately.

Preferred Experience and Skills:

• GMP quality experience with biological drug substance or drug product.
• GMP experience with qualification of equipment.
• Experience with Quality Risk Management.
• Project Management experience in a highly regulated industry.
• Experience with Kneat, SAP, Trackwise and/or GLIMS

NC: QA Manufacturing Specialist (CQV) (232651)


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
North Carolina

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