Quality Control Analyst (Bedford,Ma)

Whitridge Associates Bedford , MA 01730

Posted 5 months ago

No one with less than 2 years industry experience will be considered.

No third party candidates will be considered.

Candidates MUST have a minimum of specific domain experience and no resumes will be considered without complete contact information including full name, address, phone number and email address.

Quality Control Analyst is responsible for the day-to- day oversight of analytical testing atcontract laboratories and contract manufacturing facilities for testing on development andcommercial pharmaceutical products and Active Pharmaceutical Ingredients (API).

  • Interacts with internal multidisciplinary teams to ensure successful delivery schedules ofanalytical test reports or certificates.
  • Provides contribution to projects associated with drug substance and products
  • Review and Approve drug substance and drug product (commercial and CTMs)analytical testing at contract laboratories.
  • Monitor stability activities including maintenance of master stability protocols andindividual study plans, set up of stability studies, and assist in writing of timely stabilityreports.
  • Approve and issue component and/or drug product and packaged clinical trial material Cof As.
  • Investigate and resolve analytical test failures (OOS and atypical results)
  • Monitor contract lab activities to ensure compliance and timeliness of C of As and reports
  • Summarize and report laboratory performance metrics
  • Represent QC in cross-functional teams for products and projects
  • Participate in audits, as required
  • Contribute to company quality systems
  • Assist in CMC section preparation for regulatory submissions

Knowledge and skills (general and technical):

  • Knowledge of current Good Manufacturing Practices (GMPs) including laboratorycontrols and good documentation practices
  • Must be able to work independently and as a member of cross-functional teamscomprised of internal and/or external contacts

Education:

Minimum of Bachelor's degree in a scientific discipline (e.g., biology, chemistry, pharmacy) orrelevant field of study and 2 years of experience in an FDA-regulated biotechnology,pharmaceutical or medical device company with direct exposure to laboratory operations,documentation practices, and quality systems, or an advanced degree. The desired candidate willhave experience in testing pharmaceuticals and possess a good analytical background with greatattention to detail

About Whitridge Associates:

Whitridge Associates is a 25 year old business and technology staffing company with an unrivaled reputation in the consultant community endorsed by being awarded Best of Staffing , Talent, the last two years. Our focus is on a long term relationship with out consultants by providing contributions to both your Health and Dental insurance along with matching in your 401K.

We re not focused on getting you just a job we re focused on keeping you employed by Whitridge for many years.


Associated topics: blood collection, medical laboratory science, microbiology, mls, scientist, technician iii, technician iv, technician laboratory, technologist, testing
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Quality Control Analyst (Bedford,Ma)

Whitridge Associates