Job Description
Job Description Key Responsibilities: - Maintain cGMP documentation relevant to the duties and responsibilities assigned for environmental monitoring of the facilities and utilities
- Perform environmental monitoring of classified cleanroom areas
- Assist in the performance and documentation for environmental monitoring of the facilities ,water systems, cleaning verification sample collection and analysis
- Aide in the maintenance of environmental monitoring trend data to drive continuous improvements and identify trends
- Participate in Microbiology material inventory control
- Provide support to facility to resolve non-conformance issues and identify corrective and preventative actions as related to environmental monitoring excursions as per PPS QMS systems.
- Maintain laboratory instrumentation required for testing.
- Assist in the review of test data and report any deviations to management
- Interact and coordinate activities with other departments and external vendors to support and meet the facility goals and objectives
- Participate in projects involving the Quality Control and/or Microbiology departments
- Handle and dispose of biohazard material in compliance with OSHA and Standard Operating Procedures
- Perform additional activities assigned by management
Education Requirements: - Bachelor's Degree in life sciences related discipline is preferred or 1 years equivalent experience is required
Work Experience: •Experience with common microbiology lab instrumentation including autoclaves, light microscopes, and biohazard safety cabinets.
•Previous work within a laboratory or manufacturing environment is preferred
Functional Or Technical Skills: - Working knowledge and practical experience with good laboratory practices and competency with microbiology techniques such as Gram staining, isolation plating, aseptic practice, and microorganism identification methods
- Practical hands on experience with basic lab equipment such as pH meters, balances, water baths and other equipment common to microbiology methods.
- Proficiency in the Microsoft Office applications (Word, Excel, Outlook and Access)
- Understanding of basic lab safety, bio-hazard and chemical waste disposal practices
- Training in cGMP is preferred (may be completed after employment)
Physical Demands: - Ability to wear gowning materials for extended periods of time
- Required to maintain good personal hygiene.
- Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected
- Periodic lifting up to 20 pounds
- Long periods of standing and walking
- Must pass medical clearance to wear a tight-fitting respirator
- Must pass pre-employment physical and drug screen
- The employee may be exposed to materials of potential high potency and/or toxicity in a limited capacity
Job Tags
Work experience placement,