ProClinical is currently seeking a Manager, QA Analytical, for a biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics, primarily for oncology. This position is responsible for supporting GMP Quality Assurance (QA) in maintaining company Quality Systems related to clinical development, manufacture and testing of clinical supplies and commercial product for large and small molecules. The Manager, QA Analytical position will review and approve analytical data supporting GMP QA. This is a permanent position based in Pennsylvania.
- Maintain company Quality Systems and procedures for associated with QA Analytical
- Verify analyses of experimental and stability samples are coordinated and conducted in accordance with cGMPs, company SOPs, methods and protocols.
- Conduct, Review and/or Approve laboratory documentations including deviations/investigations, OOS, and change controls.
- Support the management of contract laboratories and analytical service providers for QA.
- Develop, author, implement and revise company Quality Analytical SOPs.
- Provide training as needed on GMPs and company Quality Management System.
- Perform and Participate in internal and external cGxP audits as required.
- Review and approve analytical data/documentation, including, but not limited to batch records, laboratory notebooks, COAs, protocols, methods, and reports related to drug product and drug substance.
- Identify, troubleshoot and communicate potential issues by perform data trending and statistical analysis.
- Generate company COAs supporting disposition of drug substance, drug product and packaging of supplies for clinical and commercial use.
- Convey results of analytical studies and participate on project discussions/teams as applicable.
- Support cross functional GxP audits and activities as required.
- Prepare and/or review the associated analytical sections prior to regulatory submission.
- Work under challenging deadlines and be accountable for completing work within specified time periods.
- Other duties as assigned by management.
Skills and Requirements:
- Bachelor’s degree in scientific/life-sciences or related field.
- A minimum of 5 years of experience in the Pharmaceutical or Biopharmaceutical industry with at least 3 or more years of analytical experience in an FDA quality/regulatory related function required.
- Good understanding of analytical method validation, pharmaceutical drug substance/drug product analytical technique and microbiological testing requirements. Direct experience laboratory equipment/testing and software preferred (e.g. UV, IR, MS, NMR, XRPD, HPLC, GC)
- Good theoretical knowledge quality management systems and quality system practices in the pharmaceutical industry. Experienced with CMO relationship/Quality System management preferred.
- Ability to manage and prioritize projects under tight deadlines.
- Strong written, oral communication, interpersonal, and organization skills.
- Strong computer skills including knowledge and experience using Microsoft applications including Excel, Word, and PowerPoint.
- Ability to travel 15%.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Tong on +1 646 878 6308 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.