Supervisor, Qc Analytical
On-siteBedford, New Hampshire, United States
Job Summary
Prioritize and distribute work to analysts in the QC Analytical laboratory while conducting OOS and customer complaint investigations. Perform routine analytical testing of raw materials, in-process samples, and finished products using HPLC, Karl Fischer, and other instrumentation. Complete peer reviews of executed work, perform instrument calibrations and preventative maintenance, and document laboratory activities per CGMP requirements. Write, review, and revise SOPs as needed. Train new employees and communicate with clients regarding quality system events. Works closely with Quality Assurance, Operations, and R&D staff. Requires 5+ years of relevant analytical chemistry experience in a cGMP environment.
Required Qualifications
- 5+ years relevant Analytical Chemistry experience, preferably in Quality Control, in a pharmaceutical manufacturing company
- Experience working in a cGMP laboratory
- Bachelor of Science in a scientific area of study
- Ability to prioritize tasks for staff
- Ability to make informed decisions
- Detail oriented
- Strong oral and written communication skills
- Excellent organization skills
- Office Suite experience (Excel, Word, Access, and PowerPoint)
- Ability to multi-task in a dynamic environment with changing priorities
- Resilient, can quickly move forward despite challenges
- A drive to achieve results for self, and the team, and is cable of working with limited supervision
- Positive attitude and strong team, cross team collaboration
- Honesty, integrity, respect and courtesy with leadership and peers
- Strong commitment to conducting PCI PHARMA SERVICES business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of PCI PHARMA SERVICES products and services
- Must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions
- Routine work requires walking, standing, bending, reaching, climbing stairs, lifting or carrying objects that typically weigh less than 50 lbs
- Capacity to work on several tasks simultaneously
- Able to organize and prioritize work activities
- Must be able to walk and drive between locations
- Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves
- Comfortable with working/handling of hazardous materials
- TRAVEL – <10%
Desired Qualifications
- Experience working in a CMO (contact manufacturing/development organization) preferred
- Prior leadership experience is preferred
- Master of Science in a scientific area of study and 3+ years Analytical Chemistry experience, preferably in Quality Control, in a pharmaceutical manufacturing company
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