21 CFR Parts 210 jobs

Remote or Chicago, Illinois

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Today

Job Title: Quality Auditor Locations: Remote (50 - 60% Travel is expected anywhere in US but that will be sponsored) Duration: 6 months Contract Pay Range: $40 - $43/hr. Must Have's 8+ years of Quality Assurance and Quality Auditing experience within the medical device or pharmaceutical industry Extensive experience leading supplier/vendor audits from planning through final reporting Expert knowledge of FDA regulations (21 CFR Parts 210, 211, and 803), ISO 13485, and Quality Management Systems

Easy Apply

Full-time

$40.0000 - $43.0000

Validation Engineer

Houston, Texas

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Today

Summary : We are looking for a Validation Engineer II with experience in the pharmaceutical or biopharmaceutical industry to join our growing team. Roles & Responsibilities: Develop and execute IQ, OQ, PQ validation protocols and reports for equipment, utilities, and facilities. Perform CQV activities, including Temperature Mapping for Controlled Temperature Units (CTUs). Collaborate with Manufacturing, QA, Engineering, and R&D teams. nalyze validation data, investigate deviations, and support C

Full-time

LSA QA Sr. Compliance Specialist

Portsmouth, New Hampshire

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Today

LSA QA Sr. Compliance Specialist Location: This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 7:00 AM?4:00 PM EST. What you will get: Below you will find a comprehensive summary of the benefits package we offer: Performance-related bonus. Medical, dental and vision insurance. 401(k) matching plan. Life insurance, as well as short-term and long-term disability insurance. Employee assistance programs. Paid time off (PTO). Compensation

Full-time

Validation Engineer 2

Bend, Oregon

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Today

Job Description: Client is seeking a contractor-level CSV/CQV Specialist to support a high-priority backlog of qualification and validation activities within the CQV department. This role will provide validation support for analytical laboratory instruments, computerized systems, and GMP equipment while partnering closely with both the Instrumentation and CQV teams. The successful candidate will split time supporting Dawn Bosco's CQV priorities and the Instrumentation team's CSV activities. This

Full-time

Process Engineer MS&T

Princeton, New Jersey

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Today

Process Engineer MS&T About Site Catalent's Princeton, New Jersey site is a key part of the company's cell therapy network and serves as a U.S. commercial manufacturing facility for autologous and allogeneic cell therapies. The site is equipped to support the full product lifecycle, including late-stage clinical development, process characterization, and commercial-scale CGMP manufacturing across a wide range of cell types. With flexible cleanroom suites, quality control laboratories, and an e

Full-time

USD 105,000.00 - 125,000.00 per year