QC Chemistry Analyst
- Location: Cincinnati, Ohio
- Type: Contract
- Job #36575
The QC Analyst I/II will join chemistry group to perform analytical testing, instrument qualification as required to meet QC cycle times following cGMP. Responsibilities will also include reviewing, reporting test results and ensuring that all activities within the laboratory are performed in compliance with cGMP, internal written procedures and policies. The analyst II will answer questions that arise regarding cGMP and internal requirements of a particular activity or job function.
- Execute analytical testing following in-house analytical procedures and compendia (USP, EP, JP).
- Execute method verification/validation/qualification/ transfers
- Execute laboratory investigations as needed
- Drafting documents (SOPs, specifications, technical reports)
- Execute, oversee instrument qualification as necessary
- Review data as needed utilizing LIMS, ELN, SAP, SLIM and Oracle
- Troubleshooting of technical procedures, methodology and instrumentation
- Specific understanding of the finished product sampling and testing procedures in a cGMP environment.
- Proficient in QC Release (Oral Solid Dosage, Polymers and/or Proteins) testing procedures.
- Proficient in HPLC, Dissolution, GC, KF, DSC, Particle Size, In-Vitro techniques and specialized in other wet analytical techniques.
- Proficient in LIMS, Trackwise, Empower and lean laboratory operations
- Proficient in FDA, ICH, DEA, USP guidelines, cGMP regulations and laboratory safety procedures
- Ability to react quickly to changes in project priorities and timelines
- Ability to cope with a rapidly changing work environment.
- Good interpersonal skills and ability to work effectively in a team environment.
- Commitment to continuous improvement in all areas.
- Ability to work safely; seek out and encourage safe practices
- The successful candidate will be responsible for managing their time, organizing their workload to be efficient, and have good organizational and communication skills.
Education and Experience:
- Minimum BS degree in Chemistry or related scientific field
- Approximately 3 years’ experience in pharmaceutical quality control laboratory if preferred but applicable lab experence is acceptable