QA Raw Materials Supervisor - Permanent - Philadelphia, PA
Proclinical is partnered with a pharmaceutical company seeking a QA Raw Materials Supervisor for a role in Philadelphia, PA. This position focuses on the oversight and monitoring of GMP release activities, including finished drug products.
We are a growing company focused on developing and commercializing immunotherapies based on tumor infiltrating lymphocytes (TIL). The newly created Supervisor, Quality Assurance, Raw Material Release position requires a highly independent individual with strong communication skills.
This role involves representing the Quality organization in overseeing and monitoring GMP release activities, including finished drug products. You will be a key point of contact between manufacturing and Quality teams, ensuring informed decision-making and fluency in release processes and procedures.
Primary Responsibilities:
The successful candidate will be a key point of contact between manufacturing and quality teams, ensuring informed decision-making and compliance with release processes and procedures.
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 biologics 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 QA Raw Materials Supervisor's responsibilities will be:
- 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 our 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 Iovance audits as required
- Track data for Quality Release metrics as required
- Other duties as assigned
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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