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Supervisor, Quality Assurance, Raw Material Release

Philadelphia, PA 19112

Posted: 12/11/2024 Employment Type: Direct Hire/Perm Job Category: Quality and Compliance Job Number: 616129 Is job remote?: No Country: United States

Job Description

Overview
The position will help to represent the Quality organization in the oversight and monitoring of GMP release activities, including finished drug product. The position will be a key point of contact for communications between manufacturing and Quality, with the goal of optimizing informed decision making. The position will be fluent in release processes and procedures.

Monday to Friday-standard hours.

Essential Functions and Responsibilities
•    Supervision and Development direct reports, mentoring/coaching to motivate and mentor peers/staff to foster a culture of continuous improvement, quality, and excellence.
•    Perform real-time support for escalations to ensure compliance with GMP and GDP quality initiatives.
•    Ensure appropriate and timely escalation of significant quality issues
•    Schedule and coordinate daily activities for raw material release ensuring conformance to the daily schedule and overall site compliance.
•    Apply quality compliance theories and principles to independently address a variety of issues of moderate scope. Provide guidance on controlled documents (content, quality, and document lifecycle), identifying gaps, addressing documentation needs, and suggesting process improvements.
•    Support lot release and disposition activities, as required
•    Support final product drug label issuance and reconciliation
•    Initiate and participate in standard operating procedure (SOP) revisions to improve compliance.
•    Drive continuous improvements to systems, policies, procedures, and ways of working to create a more efficient release process that is agile, nimble, compliant, and meets the needs of the business to serve autologous cell therapy patients.
•    Review of Quality System records for compliance.
•    Must adhere to core values, policies, procedures, and business ethics.
•    Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
•    Perform miscellaneous duties as assigned.
•    Provide support for audits as required
•    Track data for Quality Release metrics as required
•    Other duties as assigned

Required Education, Skills, and Knowledge

•    Minimum B.S. in biology, biochemistry, bioengineering, related technical field, or equivalent industry and technical experience.
•    Minimum of 5 years of experience in biopharmaceutical-based GMP cell therapy or bioloigcs industry. A minimum of 2 years in a Lead/Leadership/Supervisory Role is desired.
•    Quality release experience is required.
•    Detailed knowledge of Code of Federal Regulations 21 CFR 210/211 and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals; 21 CFR 1271 is a plus
•    Excellent oral and written communication skills
•    Ability to identify and resolve quality issues with others in a proactive, diplomatic, flexible, and constructive manner
•    Must be comfortable in a fast-paced environment and changing priorities
•    Experience with use of an electronic QMS, MasterControl

 

The staffing 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 and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Philadelphia, PA

Ready to embark on a new career adventure in the vibrant city of Philadelphia, Pennsylvania? Explore our job opportunities in the City of Brotherly Love and discover the countless growth possibilities this historic region offers aspiring professionals. From iconic landmarks like the Liberty Bell and Independence Hall to the mouthwatering Philly cheesesteaks and world-class art galleries such as The Barnes Foundation, Philadelphia is a treasure trove of culture and charm. With renowned theaters like the Walnut Street Theatre, professional sports teams like the Eagles and Phillies, and gorgeous outdoor spaces like Fairmount Park, Philadelphia has something for everyone. Don't miss out on the chance to make your mark in this dynamic city — browse our job listings now and take the first step towards your dream career!

Although this hasn't been an issue at Planet Pharma, the staffing 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 and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.