Quality Control Peer Reviewer Durham United States,
Recipharm is a leading CDMO (Contract Development and Manufacturing Organization) in the pharmaceutical industry employing 5,000 employees with headquarters in Sweden. One of Recipharm’s seven research and development facilities is located in Research Triangle Park, North Carolina, USA.
Recipharm has an outstanding reputation and expertise in the specialized fields of respiratory, topical and parenteral product development and analytical method development. Recipharm in RTP offers analytical, preformulation, and formulation development services in these specialized fields. Recipharm is currently expanding its capabilities with the implementation of a new GMP suite that will produce clinical trial material for non-sterile dosage forms.
The Quality Control department is a key department in the organization, responsible for the review and release of Recipharm’s testing data and report issuance. We are seeking a QC Peer Reviewer who will work independently to provide a technical review for laboratory testing data in compliance with GMP and GLP standards. This position specializes in various aspects of laboratory data and documentation evaluation and review, laboratory investigations, and a variety of routine and non-routine laboratory tasks. In this position, your key responsibilities will be to:
- Review and approve analytical data
- Review and approve experiment documentation and analytical test reports
- Review and approve method calculation and documentation templates
- Assist with instrument qualification documents and data review
- Review and approve controlled documents, notebooks and records
- Assist in writing, reviewing and/or approval of laboratory investigations
- Ensure all testing was performed per approved SOPs/methods/protocols and comply with specifications by critically analyzing the reported data and results for accurate interpretation and conclusion.
- Ensure all issues/documentation is complete prior to approval.
- Prepare and sign Certificates of Analysis
- Facilitate corrections with analyst and working cohesively with Quality Assurance to ensure time lines are met
- B.A. or B.S. degree in chemistry, biochemistry or related area (or equivalent training)
- 2+ years of experience in Pharma as a GMP analyst with HPLC, KF titration, and compendial methods
- HPLC, GC, and KF review experience
- Attention to detail and ability to work independently receiving minimal guidance
- Strong knowledge of cGMP and cGLP, and of good documentation practices
- Experience with Empower software
- 4+ years of experience as a Data Reviewer in a GMP pharmaceutical QC lab
- GC experience
- Experience working in a CRO/CDMO
***This role does not offer relocation***
Recipharm is a leading CDMO (Contract Development and Manufacturing Organisation) in the pharmaceutical industry employing some 6,000 employees. Recipharm offers manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material and APIs, and pharmaceutical product development. Recipharm manufactures several hundred different products to customers ranging from Big Pharma to smaller research- and development companies. Recipharm’s turnover is approximately SEK 6 billion and the Company operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK and the US and is headquartered in Stockholm, Sweden. The Recipharm B-share (RECI B) is listed on Nasdaq Stockholm.
For more information on Recipharm and our services, please visit www.recipharm.com
URL to this pagehttps://www.recipharm.com/careers/current-vacancies?rmpage=job&rmjob=1209&rmlang=UK
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