Senior Quality Assurance Specialist (cGMP – Pharmaceutical)
AM Technical Solutions- Who Are We:
AM Technical Solutions (AM), founded in 1994, is a proven and licensed architecture, engineering, and construction firm bringing innovative solutions to the Biopharma industry to help in the fight to save lives. Our knowledge and expertise in high-tech spaces combined with our culture-first mentality allows our team to deliver the entire scope of work for high-tech construction projects on schedule, on budget, and at the level of quality required by customers. AM Life Science being an integrated part of AM Technical Solutions brings new energy and ideas to an ever-changing industry. Our team is comprised of motivated, intelligent, capable and qualified individuals who design, execute and manage projects and programs that implement risk-based approaches utilizing scientific data and justifications to align with the regulatory and industry standards. AM Life Science takes pride in our accuracy, efficiency, and integrity, which translates into cost and time savings for our Clients.
Senior Quality Assurance Specialist (cGMP Pharmaceutical)
Boston, MA area
AM Technical Solutions is looking for a Senior Quality Assurance Specialist to work with a BioPharma client in the Boston, MA area. Ideal candidates should have a strong understanding of GMPs and have previous experience working within highly regulated pharmaceutical/biotech facilities.
Direct Involvement Opportunities:
- Responsible for being a quality contact and primary Subject Matter Expert (SME) for complex deviations for systems, processes and equipment related to engineering, facilities, automation, manufacturing, and validation.
- Supports and reviews complex deviation investigations related to manufacturing process equipment, utilities, automation, validation, and engineering.
- Acts as an advisor and makes recommendation to Quality Assurance Management for the release of equipment based on completion of corrective actions related to a complex deviation.
- Works closely with Operations, Facilities, Manufacturing, Automation, Validation, and Engineering to resolve open issues resulting from equipment failures, issues and deviation record reviews.
- Leads the QA review and assessments of deviations; includes performing risk assessments, leading root cause analysis investigations, tracking, follow-up, close out and reporting/trending.
- Reviews and approves Corrective and Preventative Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
- Leads the identification and implementation of improvement opportunities for issues related to automation issues, equipment, and validation failures.
- Working with all departments to guide the timely completion of Deviations, CAPA, Corrective Work Orders, Change Controls, and Investigations.
- Proficient in entering information from deviations into TrackWise and generating reports from these systems.
- Provides QA oversight to equipment lifecycle activities including commissioning, qualifications and preventive maintenance.
Qualifications, Skills, And Experience:
- Bachelors degree in Engineering, Chemistry, Biology or related field.
- 5+ years of GMP-related experience in biopharmaceutical or pharmaceutical manufacturing facilities.
- Thorough knowledge of cGMP/GDP and international regulatory requirements.
- Operations experience in a GMP environment.
- Ability to prioritize daily activities in order to meet internal and external customer needs in a fast-paced environment.