QC Analytical - Group Leader
About The Position
The QC Analytical Group Leader performs routine and non-routine analytical testing of pharmaceutical products, raw materials, validation, stability, and process samples in a GMP-regulated laboratory. The role uses laboratory instruments and equipment according to established procedures and is responsible for creating, reviewing, and approving GMP documentation, including test records and, as assigned, validation protocols and reports, test methods, and equipment records. The Group Leader serves as a technical resource, trainer, and troubleshooter for the department; recommends operational or technical improvements; communicates within the group; coaches and develops direct reports; plans and monitors workflows; approves employee time entries; and supports company policies and procedures. The position is full-time, Monday through Friday, generally 8 a.m. to 5 p.m., and weekend work may be expected. The site is not accessible by public transportation. Candidates within commuting distance of Sanford, North Carolina, are encouraged to apply.
Requirements
- Bachelor of Science in Chemistry or Biochemistry.
- At least 2 years of experience working in a laboratory environment; QC laboratory experience is preferred.
- Experience working with analytical standards, reagents, and laboratory instruments.
- Successful hands-on analytical testing experience in a Good Manufacturing Practices (cGMP) environment.
- Understanding of and ability to perform analytical testing using equipment such as UV-VIS, HPLC, UPLC, pH, appearance, osmolality, TOC, and conductivity instruments.
- Ability to perform complex mathematical problems and complex data analysis.
- Accurate pipetting skills.
- Authorization to work indefinitely in the United States without restrictions.
Nice To Haves
- QC laboratory experience.
- Previous leadership experience.
Responsibilities
- Perform routine and non-routine analytical testing of pharmaceutical products, raw materials, validation, stability, and process samples in a GMP-regulated laboratory.
- Use laboratory instruments and equipment in accordance with established procedures.
- Create, review, and approve GMP documentation, including test records and, as assigned, validation protocols and reports, test methods, and equipment records.
- Act as a technical resource, trainer, and troubleshooter for the department.
- Recommend operational and technical improvements.
- Communicate effectively within the group.
- Coach and develop direct reports.
- Plan and monitor workflows.
- Monitor and approve employees’ time worked through the time-entry system.
- Support and promote company policies and procedures.
Benefits
- Comprehensive medical coverage.
- Dental and vision options.
- Life and disability insurance.
- 401(k) with company match.
- Paid vacation and holidays.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
