- Microbial Limit test as per USP.
- Rapid microbial testing of finished products and raw materials using Biolumix / Soleris is an additional advantage.
- Environmental monitoring program of production and Microbiology area.
- Media preparation &Growth promotion testing.
- Collection and analysis of cleaning validation samples.
- ATCC Culture identification and population verifications.
- Recording of testing and results in appropriate logbooks and lab automation programs.
- Performs transactions for sample entry and results recording.
- Performs miscellaneous validation for basic microbiological methods where applicable.
- Compiles all data obtained from testing and observations and completes report summaries.
- Recognizes OOS or out of trend and under the direction of QC management assists in lab investigations.
- Complies with all regulatory/ in-house requirements (may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP,GLP, documentation) when performing the assigned activity.
- Must be able to work extended hours as needed and occasional weekends.
- Other duties and responsibilities as assigned.
Other Responsibilities Including Safety: - Works in a safe and responsible manner to create an injury-free and incident-free workplace.
- Complies with all job-related safety and other training requirements.
- Keeps management informed of area activities and of any significant problems.
|
Education & Qualification: - BS /MS in Chemistry or related scientific disciplines
- 1 year experience in basic microbiology laboratory techniques
- Minimum of 1-3 years QC lab work experience with industry experience in dietary supplements, food or OTC manufacturing.
Certifications, Licenses, Credentials: Skills & Ability - Ability to maintain integrity and honesty at all times and to communicate with transparency.
- Ability to work independently or as part of a team.
- Solid understanding of cGMP’s and GLP and is familiar with 21 CFR Part 11
- Strong working knowledge of Microsoft Word, Excel.
- Good documentation practices and able to write simple, clear reports
- Meets commitments on time and practices time-management skills
- Seeks to identify continuous improvement needs
- Experience with Shimadzu LC2010, Nexera, GC2010, Thermo ICP-MS, Labsolution and Waters Empower Lab Software a plus.
Physical Requirements (lifting, etc.): - Ability to navigate office, lab, and/or plant floor working environments.
- Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances and leaning over equipment as well as kneeling on the floor to clean under the equipment.
- Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators.
- On occasion may need to lift up to 20lbs
Work Environment (Office, Warehouse, temperature extremes, etc.): - Work is regularly performed inside a laboratory environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.
- May execute up to 20% of their work at the bench level either standing or sitting on a stool.
- Work performed in a standard office environment is without unpleasant or hazardous conditions.
|
