What are the responsibilities and job description for the Stability Supervisor position at Veranova?
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 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).
- Develops direct reporting chemists through goal setting, performance management with regular review (i.e. 1 on1 meetings).
- 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.
Essential
- Bachelor’s degree in chemistry or related science
- Minimum of 5 years cGMP laboratory experience
- Minimum of 3 years stability program experience
- Ability to communicate effectively with impact internally and externally
- Builds collaborative relationships cross-departmentally
- Seeks opportunities for continuous improvement
- Able to make decisions after evaluating current laboratory workload
- Adaptability due to changing production demands due to customer needs
Desirable
- Proficiency in standard QC laboratory equipment (HPLC, GC, FTIR, UV, KF, etc.)
- Adept at report writing and root cause analysis
- Background in data trending
- Supervisory experience/leading teams
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.
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