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Specialist QA I - Manufacturing Oversight
5800 Park of Commerce BLVD NW Boca Raton, FL 33410 US
Job Description
The QA Specialist I - Manufacturing Oversight performs manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include, but are not limited to, real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor.
Qualifications
ESSENTIALS OF THE JOB:
- Possess an understanding of Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}).
- Perform Quality Assurance review and approval of Event notifications.
- Possess and understanding of cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600.
- Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies.
- Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers) and their associated activities, as required.
- Review and release of Plasma pools to manufacturing.
- Review all manufacturing support documentation (logbooks, log sheets, charts, etc.)
- Perform review and release of raw materials in LIMS/SAP.
- Perform audits of Nitrogen receipt process.
- Assist with quarantining and release of critical systems, equipment, and controlled environments.
- Rotation amongst QA Specialists to provide 24/7 manufacturing oversight coverage. Required to work 12-hour shifts (07:00 AM to 07:00 PM or 07:00 PM to 07:00 AM). Must be available to support coverage on either shift.
- Assist in other oversight activities, as needed.
- Coordinate and perform any additional activities or projects assigned by QA Management.
- Experience with LIMS and SAP is preferred.
Education Requirements: Bachelor's Degree preferred but can be offset by experience.
Experience Requirements: 1-3 years’ experience in pharmaceutical or biotechnology industry or other related industry preferred
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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