Quality assurance specialist
DUTIES: Support day-to-day quality assurance oversight of the GMP manufacturing and quality control testing of purified iPBMCs which serve as an essential critical raw material in the TIL drug product manufacturing process. Responsible for assessing GMP compliance to Food, Drug, and Cosmetics Act regulations through release of raw materials and components for use, controlled document and label issuance, facilities audits and inspections, aseptic process observations, good documentation review, anomaly investigations, data conformance, and product disposition. Prepare and organize release documentation in support of lot disposition, ensure GDP, maintain high level of quality on site, and other duties as required.
May be assigned to various, unanticipated sites throughout the United States.
REQUIRED: Education: A Master's degree in in a pharmaceutical or life sciences field. Experience: At least one year in position offered or in a QA role, in the pharmaceutical industry. Skills: GMPs; QA work involving deviation of CAPAs, change control, laboratory investigations/OOS/OOT; manufacturing of Sterile Drug substances and Drug Products; QA oversight of QC testing; QA release of raw materials in GMP compliant manner; use of GDP [review of QC in-process and release testing records, review of environmental monitoring data, laboratory investigations, method validations, deviations, change controls, and CAPAs]; support internal audits and regulatory inspections; eDMS, MasterControl and MES. Hiring requirement: background checks
SALARY RANGE: $125,000 - $136,000 per year
BENEFITS & COMPENSATION: Medical/dental/vision/income protection plans; HSA ; paid time off & parental leave; EAP; wellness programs; legal & identity theft insurance; 401(k); stock purchase plan; professional development; annual cash bonuses & long-term incentives.
To apply, email resume to [email protected] and include "Quality Assurance Specialist (GMP/TIL) role" in the subject line
Recommended Jobs
Caregiver - Warrington, PA
Are you an exceptional caregiver? Do you have what it takes to make a positive difference in the lives of older adults? Exceptional caregivers not only have the skills necessary for the job, but …
Development assistant
NOVA (Network of Victim Assistance) is a comprehensive victim services organization in Bucks County. With a 50+-year history, NOVA has expanded to include a continuum of prevention and direct service…
Land Surveyor - PLS
Webuild ( ) is actively seeking a skilled and experienced Professional Land Surveyor (PLS) to take a leadership role within an expanding land surveying group with a portfolio includes a wide variety …
Locum - Physician - General Medicine
This job is part-time, as needed. Provider’s own office locations- Provider must have their own office # Sinking Spring, PA- 2 day per week needed You can choose to work either 4 hours a…
Server/Waitstaff
Tillie's Restaurant, 308 36th Street, Mc Keesport, Pa, Usa in Mc Keesport, PA is looking for one server/waitstaff to join our 38 person strong team. We are located on 308 36th Street. Our ideal candi…
Analyst
Lensa is a career site that helps job seekers find great jobs in the US. We are not a staffing firm or agency. Lensa does not hire directly for these jobs, but promotes jobs on LinkedIn on behalf of …
Cleaning Technician
Job Description Job Description PART-TIME Professional Cleaning Position, Monday through Friday, daytime hours will vary each week. Hiring immediately. No nights, weekends, or major holidays. Sta…
Safety Manager
Join Our Team Safety Manager iBUILT is searching for an experienced Safety Manager to join our team in Berwick. As a safety manager you must have excellent attention to detail to identify hazards. Yo…
Automotive High Performance Engines Instructor - Relocation
Job Description Job Description This position is located in Laramie, WY and will require candidates that have been offered the position to relocate to the surrounding area. ***No teaching exper…
Radiology Technologist Advanced (Outpatient)
Are you interested in a rewarding clinical career that makes a direct, meaningful impact on patient care? Want a work environment that values employee development and well-being? Join UPMC Mercy as…