Senior Quality Assurance Specialist

Job Listing No: 9740000

Senior Quality Assurance Specialist

Details: Search Terms: Quality Assurance Specialist, Sr. QA Specialist, CMO, GMP, Contact Manufacturing, Quality System Management, CMC, deviation and investigations, test method qualification, validation, tech transfer, process validation, CMC participation, training, and auditing, quality systems,, investigations, change controls, batch disposition, external and internal auditing, Development Quality Organization, compliance, Good Manufacturing Practice (GMP), COAs, SOPs, GMP controlled document, CMC, GMP documentation, Quality Assurance Manager, Sr. QA, Quality System Management, GMP System, CQA, cGMP, Quality Assurance Manager A Global Clinical Research company is looking for a Sr. Level Quality Assurance Specialist with previous CRO or Contract Manufacturing Organization experience and skills in Trackwise. Market Rate, c ommensurate with education and work experience . We are available for W2/1099/Corp-to-Corp Consultants. IMMEDIATE RESPONSE!! INTERVIEW AND START ASAP! Please forward resume (word document) to REQUIRED SKILLS: • B.S./B.A. in Science related field (or equivalent) with minimum 3-5 years of pharmaceutical or biotech industry experience. • Direct/recent experience managing drug product manufacturing CMOs (Contract Manufacturing Organization) for early and late stage biologic clinical products . • Direct experience with managing analytical test method validation at CRO’s is preferred. • Knowledge and experience with all aspects of Quality System Management , lot disposition, deviation and investigations, test method qualification and validation, tech transfer, process validation, CMC participation, training, and auditing . • Thorough working knowledge of regulated GMP systems. • Experience with pharmaceutical development processes. SUMMARY: • Develops and maintains quality systems to meet US and EU requirements, including deviations, investigations, change controls, batch disposition, external and internal auditing, to support the Development Quality Organization and ensuring compliance to Good Manufacturing Practice (GMP). Provide support for review and approval of Specifications, COAs, SOPs, and other GMP controlled documents as required. • Work with Internal and External CMC team members on a day-to-day basis to review and approve bulk drug substance and drug product GMP documentation as well as participate in the resolution of CMO and CRO operational issues. • Supports managing the compliance of bulk drug substance and drug product CMO’s , as well as associated CRO’s, to ensure manufactured product meets GMP requirements including writing and/or reviewing quality agreements, review and approval of CMO/CRO deviations, change controls and investigations, master and executed batch records, method qualification and validations, regulatory documentation updates, track quality related issues, and maintaining effective working relationships with multiple external partners. RESPONSIBILITIES: • The ability to be an independent decision maker for assessing suitability of manufactured drug substance for further processing and drug product for use in human clinical trials. • Develop, implement and maintain processes and procedures to support quality systems specific to the DQA organization; Ensure processes and procedures are adhered to and consistent with GMPs. • Write, review and implement Standard Operating Procedures (SOPs) to support CMO / CRO operations for bulk drug substance and drug product. • Review and approve deviations, investigations, and change controls affecting both internal and externally approved process and products. Approve all appropriate documentation, corrective action recommendations and final actions. • Review and evaluate existing Development Quality Systems for effectiveness and efficiency pertaining to the day to day function of CMO/CRO operations; seek and incorporate feedback from peers. • Review and approve specifications, method qualification and validation documentation, as well as associated Regulatory Documentation where appropriate. • Ensure CMO compliance to GMPs and Eisai expectations. Review and approve master and executed CMO batch records. • Support Internal / External Audit functions as required. I am very excited to hear back from you and look forward to speaking with you and your referral as soon as possible. Please call me direct at #610-822-1256 to discuss details or forward you resume (WORD document) directly to Thank you in advance for any referrals. Keywords: Quality Assurance Specialist, Sr. QA Specialist, CMO, GMP, Contact Manufacturing, Quality System Management, CMC, deviation and investigations, test method qualification, validation, tech transfer, process validation, CMC participation, training, and auditing, quality systems,, investigations, change controls, batch disposition, external and internal auditing, Development Quality Organization, compliance, Good Manufacturing Practice (GMP), COAs, SOPs, GMP controlled document, CMC, GMP documentation, Quality Assurance Manager, Sr. QA, Quality System Management, GMP System, CQA, cGMP, Quality Assurance Manager I welcome any questions or suggestions you may have at this time and look forward to hearing from you or any referrals (up to $1,000 referral bonus) you may have to provide the best Sr.QA candidates for the positions outlined above. Thank you for taking your time to read this posting. Rose Chu Vice President Pharmaceutical, CRO, Biotech, Medical Device Global Employment Solutions, Inc. One Presidential Blvd. North, Suite 310 Bala Cynwyd, PA 19004 610.822.1256 phone Referral Bonus Program ***Please call for details***

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