Aseptic Manufacturing Technician

Yoh has a long-term contract opportunity for an ASEPTIC MANUFACTURING TECHNICIAN to join our client in Raleigh-Durham, NC.

JOB RESPONSIBILITIES:

- The Aseptic Manufacturing Technician will participate within a specialized, self-directed work team and will possess proficiency in all production unit operations to include drug formulation, fill-finish operations, visual inspection and secondary packaging.
- Fill-Finish Operations - Set up and operate the filling line with minimum down time and interventions to produce finished dosage forms that meet the safety, identity, strength, quality and purity attributes. Conduct activities following proper aseptic procedures in accordance with SOPs and batch record instructions. Perform all staging, set-up, cleaning, sanitizing and decontamination activities to support the fill-finish operations.
- Visual Inspection - Perform 100% visual inspection of bright stock vials. Perform cleaning/clearance, staging, set-up and batch reconciliation activities to support the inspection operations. Record, categorize and trend inspection rejects to comply with GMP quality control monitoring requirements. 20%
- Secondary Packaging - Set up and operate the packaging line with minimum down time and interventions. Perform all cleaning, line clearance, staging, set-up and batch reconciliation activities to support the packaging operations. Record, categorize and trend packaging rejects to comply with GMP quality control monitoring requirements.
- Drug Formulation - Formulate and sterile filter drug product in accordance with the Master Batch Record and high-hazard substance containment practices. Perform staging, cleaning, set-up, API handling, and decontamination activities to support formulation operations.
- Documentation - Document all production and maintenance activities on the master batch record or ParCS to comply with GMP requirements. Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns. May create, revise, and review Standard Operating Procedures (SOP) and Master Batch Records as necessary to support Parenteral Operations

JOB QUALIFICATIONS:

- High School Diploma required and Associate's Degree is desirable
- Pharmaceutical and parenteral manufacturing experience required
- An understanding and working knowledge of pharmaceutical/parenteral manufacturing technologies including aseptic manufacturing techniques.
- Documentation activities require computer competency.
- Knowledge of microbiological principles is desirable.
- Requires the lifting of heavy objects and pulling heavy objects (up to 50 lbs) using a pallet jack.

DISCOVER ALL THAT\'S POSSIBLE WITH YOH. APPLY NOW.

RECRUITER: Tonya Allen

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading workforce solutions.

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