Quality Control Analyst I

Responsibilities:
- Test and analyze incoming materials (intermediates, finished products, swab samples) and other samples.
- Prepare, maintain, and review thorough records/documentation (solutions, sample preparation, investigational/experimental samples).
- Support laboratory investigations into Out of Specification/Out of Trend results or other lab events.
- Revise documentation such as SOPs, test methods, and specifications.
- Coordinate and send materials for contract laboratory testing.
- Ensure compliance with DEA and site requirements for controlled substances (handling, use, disposal).
- Perform verification of compendial methods.
- Provide training to other analysts on activities where expertise has been developed.
- Perform peer review on documents (may become full-time).
- Assist with stability program activities (sampling and statistical analyses).
- Assist with sampling of incoming materials as needed.
- Maintain safe work areas and perform duties per company policies, cGMPs, SOPs, and batch record instructions.

Qualifications/Requirements:
- Bachelor’s degree (preferably Chemistry or Microbiology) or equivalent; minimum 3 years progressive Quality Control Laboratory experience.
- Solid analytical chemistry understanding (HPLC, GC, FTIR, UV-Vis, and other techniques).
- Working knowledge of cGMP, DEA, and applicable regulatory requirements.
- Prefer experience with Laboratory Information Management Systems (Labware LIMS and/or Empower).

Skills/Abilities (Also Good to Have):
- Proficiency with MS Office, LMS, ERP (SAP/Oracle), and LIMS/Trackwise/Qdocs.
- Technical writing; strong written and oral communication.
- Ability to collaborate, self-direct, organize/prioritize, and be detail-oriented.

Problem Solving:
- Solve moderate-scope problems using analysis of data; exercise judgment; recommend methods/procedures.

Application:
- Apply through internal career site on Twist.