QC Project LeadLewes, DE
As a team member of the Quality Control group, helps to ensure that the site follows all Federal, State and company mandated quality compliance programs with emphasis on proper current, Good Manufacturing Practices, (cGMP documentation auditing and testing).
Essential Duties and Responsibilities
- Maintain the Elemental Impurities Program for the company.
- Support the laboratory compliance with data integrity enforcement.
- Organize and execute the qualification of laboratory instruments as needed.
- Assist troubleshooting of instruments including ICP-MS, IC, HPLC, GC, AA and FTIR.
- Assist with customer compliant investigations as needed.
- Assist Quality Control Supervisor/Manager with validations, method development and
projects as needed.
- Assist in technical problems and develop solution ideas with little help or supervision.
- Complete investigations with little to no supervision.
- Perform other duties, as assigned.
- Honesty, integrity, and the ability to work collaboratively, respectfully and safely.
- Effective clear and concise communication.
Education and/or experience
- Minimum Bachelor degree in science a related field.
- 5+ years of work experience as a Chemist within the pharmaceutical, active pharmaceutical ingredient (API) or medical device industries
- Experience with method validation/verifications and development.
- Experience operating and troubleshooting analytical instrumentation.
- Ability to work independently.
- A natural problem solver with a sound working knowledge and application of formal root
- cause analysis tools.
- Demonstrate ability to organize self and others, with a positive, proactive approach to
- changing priorities.