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QC Analyst 2

Franklin Ctr, PA 19341

Posted: 10/02/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 614091 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 25-28.66/hr **salary will be commensurate with experience 

Job Description:


The QC Analyst 2 will contribute to the success of the operation by providing accurate, GxP-compliant analyses of clinical biopharmaceutical products and by participating in assay qualification and validation studies. Biopharmaceutical manufacturing runs typically cost in excess of 1$ million each and reach many times that for larger, phase 3 campaigns, while stability studies cost several hundred thousand dollars each, and this individual has an important role in ensuring that release and stability testing generates accurate results, without delays or compliance issues. The individual will help maintain the biochemistry laboratory systems, assist in training other analysts, help maintain SOPs and other documents, and promote an orderly and efficient laboratory workplace.

Knowledge/Skills/Abilities:
  • BS in biological or chemical sciences or equivalent 
  • Minimum of 2-4 yrs working experience in a cGMP Quality Control, analytical development, analytical transfer or validation department in a FDA-regulated industry.
  • Knowledge of principles, concepts, and practices in QC testing of protein biopharmaceuticals.
  • Hands-on experience with at least two techniques, such as HPLC, capillary electrophoresis, ELISA, or SDS-PAGE, used for analysis of recombinant proteins.
  • Knowledge of GxP requirements and ICH/FDA/EMA guidelines.
  • Ability to identify and help investigate assay and equipment problems.
  • Fluent in English, good written communication skills; good interpersonal skills.
  • Team player who can excel in a hands-on entrepreneurial environment.
  • Physical requirements: handling of laboratory equipment, chemicals, and biological materials.
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About Franklin Ctr, PA

Ready to take the first step towards a fulfilling career in Franklin Center, Pennsylvania? This vibrant area, nestled in the heart of beautiful Bucks County, offers job seekers a unique blend of opportunities for growth and success. From its close proximity to iconic attractions like the historic Fonthill Castle and the bustling Peddler's Village, to its thriving arts scene featuring the James A. Michener Art Museum and the Bucks County Playhouse, Franklin Center is a hub of culture and charm. With delectable local cuisine, picturesque parks like Peace Valley Park for outdoor enthusiasts, and easy access to Philadelphia's professional sports teams and renowned venues, this region promises an enriching career experience like no other. Explore our job listings now and discover the endless possibilities waiting for you in Franklin Center, Pennsylvania!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.