- Responsible for the day-to-day Supervision of QC laboratory personnel.
- Has a good understanding of analytical instrumentation such as: HPLC, GC, ICP-MS & ICP-OES.
- Responsible for managing the work load to ensure flow of samples and timeliness of results in an appropriate manner to support the needs of Manufacturing.
- Stay current on publications released by USP, FDA and other pertinent regulating bodies as well as ISO 17025 requirements to ensure the Quality Control Laboratory complies in the area of analytical applications, release specifications, and documentation practices.
- Will assist QC Management in compliance audits as they pertain to the Quality Control Laboratory, and will assist with developing strategies when addressing audit findings.
- Initiate and or assist with the review of sourcing, material, and finished product specifications.
- Assist laboratory personnel in resolving Out-of-Specification and Out-of-Trend results in the laboratory. Will aid in determining re-sampling or retesting procedures that are scientifically sound in efforts to determine the cause of the OOS or OOT and implement corrective actions when necessary.
- Review and sign off on OOS/OOT reports and review and sign off on Certificates of Analysis and other laboratory reports.
- Ensure laboratory personnel are working in a safe manner; ensure hazardous waste is stored, handled, and disposed of in accordance to state and federal regulations; and, understand and sign-off on waste manifests.
- Undergo annual training as appropriate to suffice regulating bodies, and work with the Safety department in addressing laboratory hazards.
- Oversee and review stability and release testing on raw materials and finished products performed by laboratory personnel or contract laboratories.
- Ensure the most current Standard Operating Procedures (SOPs) and in-house test methods and/or compendial methods are being followed.
- Follow current Good Manufacturing Practice (cGMP) documentation guidelines to record all procedures or other records in a timely fashion.
- Maintain a safe working environment and ensure that all equipment used in testing procedures are calibrated and properly maintained.
- Communicate effectively with other departments within the organization and function within a team environment.
Prior Supervisory or Team Leadership experience including a minimum of three years of laboratory experience in a cGMP facility is required. Experience with the operations of laboratory instrumentation, trouble shooting, and the generation and revision of SOPs, test methods and Certificates of Analysis.
Effective interpersonal, self-motivation skills and the ability to interact with all levels of personnel.
Education and Experience:
Bachelor of Sciences (B.S.) or Bachelor of Arts (BA) degree in Chemistry or a related science.
Why is This a Great Opportunity:
Use your experience to make a difference! Excellent benefits.