IN: QPIP (2) Spots (232101)

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Job Description:

Provide person-in-plant support for the tech transfer and GMP production of client Vaccine

Key Responsibilities

Perform review and approval of equipment and facility qualification, technical documents, raw material specifications, analytical methods, and master batch

records to ensure clients products and processes comply with cGMP requirements. Following successful tech transfer, support day-to-day quality oversight for

production activities in the manufacturing plant, including identification of risks, deviation and CPA management, change control, and batch documentation review

Support regulatory submissions and inspection readiness activities. Apply cGMP regulations and other FDA and international requirements to all

aspects of the position

Skills:

Minimum of 8 years working in an FDA regulated environment Extensive experience with biologics manufacturing operations or quality assurance. Extensive experience in aseptic processing

Detailed knowledge of cGMPs related to pharmaceutical production. EXPERIENCE in being a PIP along with Strong interpersonal and written/oral communication skills

Ability to quickly process complex information and make critical decisions with limited information required PLUS’ Experience in vaccines production. Proficient in applying process excellence tools and methodologies

Experience working with external manufacturers

Education:

Bachelor’s Degree with a concentration in engineering, science, or an equivalent technical discipline

IN: QPIP (2) Spots (232101)

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
ASAP
State
Indiana

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