PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, employing a global team of skilled professional and experts that span across strategically located offices in the United States, Europe, Asia, and the Middle East. PSC operates in 52 countries globally and has served thousands of clients to date.
We focus on providing quality consulting services to ensure our client’s success. PSC provides cost-effective solutions, while providing exceptional technical capabilities and customer service to our clients for all projects ranging from supplier quality audits to greenfield projects. We understand that the world of life science is evolving rapidly, and we must continue to offer new products and services to meet our customer’s expectations.
We’re looking for a QA Specialist to join our team.
- Support internal quality systems.
- Assure compliance with current GXP and EU regulations.
- Participate in quality audits and inspections including FDA and other regulatory agencies.
- Support supplier control program including external vendor audits.
- Batch record review.
- Master documentation review.
- Review of QC assays.
- Support validation of equipment and processes, including review of new protocols as well as executed protocols and reports.
- Change control review and approval.
- Develop and deploy training for pertinent quality systems.
- Support internal training program.
- Maintain current standard operating procedures and implement new procedures as needed.
- Assist with dynamic, project-based activities and system improvements.
- Assist with routine QA operations (batch record review, investigations into deviations, CAPA, training/LIMS management).
- Perform root-cause analysis and other problem-solving activities to identify corrective and preventative actions.
- Quality metrics tracking.
- Work across all disciplines (e.g., manufacturing, clinical, regulatory, R&D, etc.) to ensure that the company maintains a state of compliance.
- Collaborate with facility in creating facility procedures and other areas SOPs alignment.
- Provide support to CSV systems validation and GAMP5 best practices.
- Familiarize with EU guidelines and keep updates to the latest compliance requirements.
- - Minimum of a B.S. in Biology, Chemistry, Microbiology, or related field.
- - Minimum 3-6 years’ experience within the biotech/pharmaceutical industry.
- - Prior experience with GMP procedures is required.
- - Good communication skills and strong attention to detail.
- - Willingness to acquire new skills and ability to learn quickly.
- - Good knowledge of quality and/or GMP principles.