About this role
Job Summary
In this role, you will perform routine and non-routine testing to support product release and plant operations, including but not limited to environmental monitoring, water testing, and other laboratory functions as needed.
Essential Duties and Responsibilities
- Perform routine and non-routine product release testing, including, but not limited to, bacterial endotoxin, bioburden, particulate, silicone.
- Perform routine testing to support plant operations, including environmental monitoring, water testing, and personnel monitoring.
- Perform incoming material testing, including growth promotion testing of culture media and incoming testing of biological indicators.
- Perform microbial identification using the WID-MID software®.
- Review laboratory data as required.
- Participate in basic laboratory support functions, including cleaning and preparing materials and glassware for testing.
- Provide support for validation, method transfers, and project related work.
- Assist in preparation of work instructions, SOPs, and qualification documentation.
- Provide support during internal and external audits.
- Participate in or assist with the identification, investigation (OOS’s) and resolution of problems in the laboratory.
- Apply cGMP requirements, data integrity, and internal procedures.
- Adhere to established laboratory safety procedures.
- Meet individual and departmental goals as required.
- Work effectively as a team member with self-motivation, adaptability, and a positive attitude to support continuous improvement in laboratory functions, while also being able to independently use established methods and procedures.
- Perform other responsibilities as assigned.
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Education
- Associate’s or bachelor’s degree in biology, microbiology, chemistry, or a related scientific discipline.
Work Experience
- No minimum years of experience required.
- 1-3 years of experience in a similar role preferred.
- Experience in lab Instrumentation preferred.
- Experience working in a laboratory or cGMP/pharmaceutical environment preferred.
Preferred Knowledge, Skills and Abilities
- Proficiency in English.
- Good verbal and written communication skills.
- Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
- Able to comply with the company’s safety policy at all times.
Travel Requirements
5%: Up to 13 business days per year
## Shift
Monday- Friday 2nd Shift. 3.00pm-11.30pm.