Are you highly motivated and ready for a change and want to join a growing company in a fast-paced environment? Are you looking for a new challenge in your career? Our client, a leading provider of high quality Compounding Sterile Preparations (CSP's), is in need of an impact employee. If you would like to be part of a successful team, then you could be what our client is looking for in a QC Lab Supervisor role. This is an excellent opportunity that offers a competitive compensation package. Relocation assistance available! If this is for you or someone you know, please forward a current resume to firstname.lastname@example.org
Job Description-QC Laboratory Supervisor-2nd Shift:
- Perform and/or supervise analytical testing in our analytical testing lab. This position will report to the quality organization. Supervisors at this facility will supervise staff, maintain sample schedules, and perform quantitative and qualitative analysis of our compounded admixed product for distribution to customers nationwide. The supervisor must be familiar with and knowledgeable of cGMP/GLP and 21 CFR Part 11 procedures
- Schedule samples for analysis
- Support specialized projects
- Organize the receiving, storing and logging in of samples from the clean room or inventory
- Actively Participate in all regulatory inspections: FDA, DEA, Board of Pharmacy, and Internal Audits. Must have the ability and experience to draft submission ready responses to audit observations.
- Review and approve data generated by biologists
- Maintenance of Laboratory Notebooks
- Review and initiate the revision of standard operating procedures
- Active knowledge of current regulatory process and updates in the area of responsibility
- Coordinate Instrument maintenance with Laboratory Metrology
- Coordinate Method Transfers and Method Development
- Write and execute protocols and reports
- Understand OOS/Investigative reports
- Develop Quality Reports
- Mentor and Supervise Biologists and Technicians
- Actively participle in New Initiative involving Lab topics
Requirements-QC Laboratory Supervisor-2nd Shift
- B.S. or Masters in Biology or related field with a minimum of 8 - 10 years of pharmaceutical laboratory experience or PhD with a minimum of 5 years of pharmaceutical laboratory experience and 1 years of supervisory or team lead experience of multiple staff members.
- Experience in FDA regulated industry.
- Actively participated in audits (internal and regulatory) with independent close out of observations
- Effective organization and planning skills
- Excellent technical and verbal skills
- Must have the ability to multi-task
- Have problem solving skill set
- Computer knowledge of data collection systems and or spreadsheet software, Microsoft Word, Excel, and PowerPoint
- Understanding and experience utilizing the USP Compendia methods
- Knowledge of Environmental Monitoring Programs A PLUS!
- Knowledge of Aseptic Technique A PLUS!
- Advanced Knowledge and training of microbiology testing, GMP documentation of experiments, and Endotoxin Analysis.
- Ability to travel up to 10%
Apply Now! Send resumes to email@example.com
10% Bonus Eligibility