Provides testing and technical support in the Analytical QC Laboratory. These functions include: Processing and testing samples of raw materials, packaging components, bulk and finished products, stability samples, process validation, and cleaning validations for company and other company affiliates to guarantee that they conform to specifications and standard operating procedures (SOPs). Possess foresight to see a task that needs performing and performs the trained task without the request of management. Reviews and/or writes the following documents: SOPs, laboratory investigations, and non-routine testing protocols. Provides technical support and trouble-shooting for analytical issues internally and externally. Complies with cGMP’s and safety regulations. Maintains an environment of respect and teamwork with all coworkers. Assists management as a professional advisor and authoritative figure on issues pertaining to specialized and detailed analytical duties to support internal and external contacts. Performs more advanced analytical testing projects and investigations under the direction of Analytical Lab Management.
1. Performs testing on raw materials, in-process, finished product, packaging, and stability samples utilizing instrumentation such as HPLC, GC, FTIR, AA and ICP in accordance with approved SOPs, Component Specifications, Method Specifications, Protocols, and/or compendia.
2. Performs instrument calibrations.
3. Perform instrument qualifications, as necessary.
4. Conducts and/or assists with completion of investigations related to QNs for OOS/OOT results.
5. Attends PRT and Project meetings, as required.
6. Review and approve laboratory data generated by other Analysts for completeness and accuracy.
7. Assists with the training of other Analysts.
8. Writes, reviews and/or assists in preparation of SOP’s.
9. Identifies and implements opportunities to improve laboratory efficiency.
10. Recommends the need for new equipment or techniques to serve expanding operational and regulatory requirements sufficiently in advance of the need.
11. May be involved with the maintenance of the commercial stability program. This includes preparation of study initiations, sample pulling, preparation of data summary sheets, preparation of stability protocols, update of stability SOP’s, and oversight of stability chambers.
12. May be involved with the maintenance of the raw material and finished product retain program.
13. Performs other related duties as required.
• BS or BA in Chemistry.
• BS or BA in a Science Field and appropriate experience.
• 3-5 years Pharmaceutical QC Analytical Laboratory experience.
• 2 years Pharmaceutical QC Analytical Laboratory supervision experience, preferred.
• Working knowledge and understanding of cGMP regulations as they relate to laboratory operations.
• Knowledge and experience with HPLC analysis. Experience with other instrumentation such as ICP, GC, and FTIR, preferred.
• Experience in conducting laboratory investigations.
• Ability to lead and develop lab analysts.
• Must be professional and ethical in all activities and relations.
• Must demonstrate through example and maintain a positive attitude.
• Must exhibit the initiative to take on individual projects, eliminate roadblocks and see them through to completion.
• Capable of working both independently and as a team member.
• Ability to work and communicate well with personnel in different departments and at various levels of responsibility.