JOB TITLE: Quality Analyst I
DEPARTMENT: Quality
REPORTS TO: Quality Unit
EMPLOYEE STATUS: Non-Exempt
LOCATION: Onsite Only
WORK AVAILABLE: Full Time
JOB SUMMARY:
As a Quality Analyst, individuals will work as part of the Quality Unit, alongside manufacturing operations, participating in activities such as reviewing and approving planned and unplanned manufacturing events, reviewing processes and suppliers against cGMP requirements, performing testing, and participating in the documentation lifecycle.
DUTIES & RESPONSIBILITIES:
- Completes incoming, in process and finished goods analytical testing to ensure all specifications are met.
- Draft, review and approve documentation for planned (change control, protocols, etc.) and unplanned (deviations, corrective maintenance, etc.) laboratory and manufacturing changes/events.
- Analyze/Review process data to assess trends and propose corrective/preventive actions.
- Performs Environmental Monitoring of production areas, including sample collection.
- Reviews line clearance and setup in production areas prior to the start of a new batch or operation.
- Provides Quality approval and acceptance, including the release of raw materials, components, and finished products/preparations.
- Provides oversight and guidance of MCCPMC staff to ensure cGMP adherence during compounded sterile preparations.
- Collects retention samples and monitors drug storage requirements.
- Completes other projects and duties as required and/or necessary.
EDUCATION / TRAINING:
- Bachelor's Degree in a Chemistry, Microbiology or related scientific field, or Equivalent years of directly related experience.
- Trained in lab testing processes and procedures.
- Knowledge of USP Sterile and Non-sterile Compounding requirements and FDA regulatory requirements (i.e. 21 CFR and FDA Guidance documents specific to Drug Manufacturing).
WORK EXPERIENCE:
- Minimum of two (2) years of pharmaceutical experience in a pharmaceutical company or quality role.
- Quality-driven, results oriented, and strong attention to detail.
- Proven organizational and time management skills.
- Aptitude for decision-making and performing risk assessments.
- Good computer skills with basic knowledge of Microsoft based programs.
ADDITIONAL QUALIFICATIONS (OPTIONAL):
- Ability to work independently with little to no supervision.
- Strong communication skills.
- Proactive and hands on.