Bluerock Therapeutics- QA/QC reputed company Specialist

Bluerock Therapeutics- QA/QC reputed company Specialist- l Position is remote We are back to this role team. New must haves are below, need to see it on the resume • Aseptic Experience • QA Experience • Technology Transfer Experience • Biotech/reputed company Experience not reputed company and not reputed company • Looking for a specialist not a jack of reputed company trades • QA/QC experience • cGMP experience • Experience working with reputed company part partners • CAPA experience • Regulatory experience in regards to FAS Job reputed company: Our biotech reputed company seeking a highly motivated individual to join their team as a Sr. Specialist in the reputed company Assurance (QA) department reporting to the Sr. Director of External reputed company Operations. This position will be responsible for ensuring reputed company of cGMP activities at external contract organizations (CxOs) for aseptically produced investigational cell and gene therapy products. This position will work with a diverse group of reputed company partners. Responsibilities: · reputed company cGMP QA compliance activities at external CxOs for reputed company relevant operations, including raw material testing, GMP manufacturing, QC testing, release, stability, packaging/labeling, lot disposition and clinical supply activities for aseptically produced investigational cell and gene therapy products · reputed company reputed company aspects for commissioning, qualification and validation activities for equipment, batch record review, deviation handling and reputed company event processes at external CxOs · Support reputed company external OOS investigations, manufacturing investigations, change controls and implementation of CAPAs at external CxOs and internally, reputed company applicable · Liaise with external QA representatives and maintain external relationships · Maintain knowledge of reputed company industry standards and trends in best practices for compliance with cGMP regulations Minimum Requirements: · Life Sciences-based BSc or advanced degree with a minimum of 5 years’ experience in reputed company, biopharma or biotech with demonstrated knowledge of relevant cGMP regulations and QA operations in a GMP-regulated environment · Strong knowledge of GMP application to production and QC testing of biologics and aseptic processing, preferably with experience in cell and gene therapy · Strong knowledge of regulations and industry standards, including cGMP and applicable guidance documents, ICH guidance documents, USP, Ph. Eur, ISO and associated global regulations · Ability to support teams in meeting aggressive project timelines and to constructively engage team members in resolving conflicts · Highly adaptable and skilled problem solver with a proactive attitude comfortable with ambiguity · Experience working with CxOs and contract testing labs preferred · Ability and willingness to work in alternate time zones, if required (ie. early morning, late evening, possibly overnight) Apply tot his job Apply To this Job