Stability Coordinator Job at Veranova

Veranova West Deptford, NJ 08066

Company Description


We are a global leader in the development and manufacturing of active pharmaceutical ingredients, focused on specialist niches with expertise in highly regulated and complex chemistries. Formerly part of Johnson Matthey, we have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle.


Job Description


JOB PURPOSE

The purpose of the Stability Supervisor is to ensure that the stability program is maintained safely and right the first time. They also assist the QC Manager in ensuring the execution of departmental objectives which includes staff development.

PRINCIPAL ACCOUNTABILITIES

  • Assign daily tasks to the stability chemists to meet stability testing schedule.
  • Maintain safety and quality systems in a state of audit readiness.
  • Works with cross-functional teams (production, quality assurance, regulatory, commercial, project management, etc.) to support product campaigns defining stability requirements.
  • Leads laboratory investigations, identifying root causes and enacting effective CAPAs to improve overall laboratory performance (%RFT).
  • Reviews analytical data as required and writes necessary reports this includes stability summary reports.
  • Executes safety initiatives in the laboratory the maintain and improve work environment.
  • Updates relevant SOPs along with evaluation of current and new equipment or use in the laboratory.
  • Involved with laboratory audits through laboratory walkthroughs responding to auditor request/questions.
  • Implements and applies cGMP concepts in association with department specific responsibilities.
  • Helps QC Manager develop yearly budget and CAPEX plan to support future lab equipment and resource needs.
  • Performs CGMP Stability testing to support the stability program. This may include HPLC/GC/KF/FTIR etc...

SCOPE

  • Assists QC Manager in developing yearly budget and CAPEX plan to support future lab equipment and resource needs.
  • Responsible for %RFT (Right the First Time) in respect to analyst errors, equipment breakdowns, method issues, etc.
  • Collaborates with QC supervisors to meet testing demands.
  • Makes daily/weekly decisions around resource planning (what each chemist will be doing, what samples are tested when etc.).

Qualifications
  • Bachelor's Degree in Chemistry or related field
  • Minimum one (1 year) experience in a quality control environment
  • Able to operate standard QC laboratory equipment (HPLC, GC, FTIR, UV, KF, etc.) desirable
  • Proficiency in Microsoft Office desirable

Additional Information


All your information will be kept confidential according to EEO guidelines.

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state or local law.

All applications are carefully considered and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice.




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