Quality Control Documentation Specialist
Proclinical is seeking a Quality Control Documentation Specialist for a cutting-edge biotech company located in Philadelphia, PA.
The quality control testing programs include the responsibility to perform iPBMC (irradiated peripheral blood mononuclear cells) lot release, stability testing, method qualification and validation and writing/review of QC procedures.
Must be eligible to work in the US.
- Review and approve daily GMP quality control laboratory testing documentation at the IOVA-A facility with minimal to no errors and ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations
- Perform final result reporting and COA Generation to support product lot release with adherence to turnaround times.
- Support thorough GMP investigations for out of specification test results and other quality events.
- Manage/Support laboratory deviations and investigations
- CAPA implementation
- Support technical problem solving for issues pertaining to GMP quality control.
- Support generation and revisions of documentation, such as SOP, protocols, and reports.
- Act as a subject matter expert (SME)
- Perform peer review of laboratory data and logbooks
- Support Trending of analytical performance
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results.
- Support Health Authority inspections
- Provide input to functional laboratory meetings.
- Due to the nature of testing schedules, must be willing to work alternative shifts, weekends, evenings, and holidays, as needed. It is also expected that regular work weeks may change and may involve shift changes.
- Performs other duties as assigned.
Skills and Requirements:
- Bachelor's degree in a relevant discipline (biological sciences or equivalent)
- knowledge of biological drug development with respect to Quality Control
- Minimum (5) years of experience in the biopharmaceutical industry within a Quality Control role; experience with cell and/or gene therapy products is a plus
- Proficient in performing technical writing (e.g., test methods, SOP's, protocols, etc.)
- Successfully interface with multi-disciplined teams in a global setting
- Extremely detail-oriented with strong analytical, written, and verbal communication skills
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity. High level of ownership and accountability
- Demonstrate sense of urgency; ability to recognize time sensitivity
- Flexible and adaptable style with an eagerness to take on challenges
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
- Able to stand/sit/walk for long periods of time.
- Lift up to 20 lbs
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at +(1) 267-428-7770 or firstname.lastname@example.org.
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.