QC Sampling & Inspection Technician Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 360 employees. Reporting to the Microbiology Manager,
Job Summary:
The QC Sampling & Inspection Technician performs sampling and inspection of incoming drug substances, raw materials, and packaging components while following applicable SOP's and cGMPs. Sampling will also include sampling utilities such as purified water, water for injection, and pure steam. This role will also provide sampling & incoming inspection support for development projects.
Essential Functions / Responsibilities
Raw Material and Packaging Components Compliance Verified:- Performs routine sampling of raw materials and packaging components following applicable SOP's and cGMPs.
- Performs utility sampling for purified water, water for injection, and pure steam.
- Analyzes the results of inspection tests to ensure conformity to specifications.
- Maintains and stocks supplies required to complete sampling and inspection activities.
- Identifies and communicates actual and potential problems.
- May support/provide input for investigations and troubleshooting, with supervision.
- Writes basic investigations with some assistance.
- Able to gown to aseptic gowning standards
- Documentation and Inspection/Sampling Environment Maintained to cGMP Standards
- Performs data entry and fills out paperwork following applicable SOP's and cGMP/GDPs ensuring accuracy.
- Reviews colleagues work for accuracy in accordance with SOP's and cGMP/GDP requirements.
- Maintains and updates training records in timeframe required by applicable procedures.
- Monitors and maintain equipment certification/calibration schedules
- Writes and participates in investigations as required
- We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.
- We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.
Unither is an Equal Opportunity Employer. We are committed to providing reasonable accommodations for qualified individuals with disabilities and to ensuring equal employment opportunity for all applicants.
