Candidates in this role are responsible for the accurate and efficient of microbiological tests including aseptic processing of sterility tests in a cleanroom suite particulate matter testing via the use of a laser particle analyzer or microscopic examination endotoxin testing or other microbiology pharmaceutical testing in accordance with established procedures. Candidates Will collect and present data in a wellreasoned and accurate manner and maintain the laboratory environment according to cGMP guidelines.
Responsibilities:
- Preparing and performing microbiological tests on medical devices and pharmaceuticals as recommended by current USP FDA and AAMI/ISO regulations.
- Routine Quality Control of laboratory equipment media and microorganisms.
- Provide accurate test results to customers on a timely basis including but not limited to Bioburden Limulus amoebocyte lysate (LAL) Sterility for Medical Devices OffSite Clean Room Validation and Monitoring etc.
- Record test results accurately and legibly on all documents.
- Technical report writing including text tables graphs and diagrams.
- Assist in the training of new Laboratory Technicians.
- Follow and perform process qualifications and validations for procedures and/or equipment.
- Maintain control of test samples including logging in storage tracking and disposal.
- Monitor test status and conditions as described in Work Instructions and Operating Procedures.
- Routine maintenance of laboratory environment to include cleaning and troubleshooting.
- Report any deviations and/or nonconformities to Management.
- Suggest possible preventative and corrective measures to prevent future deviations and nonconformities.
- Inventory of laboratory supplies to maintain par levels.
- Perform onsite and offsite testing.
- Gowning and garbing for cleanroom settings.
- In cooperation with the Laboratory Manager responsible for the qualification maintenance and calibration of critical equipment.
- Update procedures for improvement to methods.
- Assist with OOS NI CAPA and Change Control processes in response to Laboratory issues.
- Driving a company car for offsite work if applicable.
- Other duties as assigned.
Qualifications :
Education:
- Bachelors degree in Microbiology or related life science
Experience:
- 13 years of experience performing basic microbiological laboratory tests including but not limited to Bioburden Limulus amoebocyte lysate (LAL) Sterility for Medical Devices OffSite Clean Room Validation and Monitoring etc.
- 1 year of experience with GMP/ISO/USP etc.
Competencies:
- A highly competent and proficient worker capable of multitasking being selfmotivated and taking initiative.
- Personal attributes should include honesty integrity adaptability reliability and positivity.
- Displays leadership skills is able to train/teach others and possesses highquality standards.
- Able to provide root cause analysis and corrective action for Out of Specification Results.
- Exhibits troubleshooting skills involving equipmentrelated issues.
- Maintains personal hygiene and cleanliness inside and outside the microbiology laboratory.
- Adherence to ISO/GMP/USP standards and completion of necessary training modules
- Abilities in mathematical reasoning armhand steadiness finger dexterity visual color differences and deductive reasoning.
- Knowledge of laboratory equipment such as microscopes velometers balance autoclaves water purification systems hood operation particulate counter membrane filtration endotoxin plate reader etc.
- Standard office equipment including computers copiers and scanners.
- Frequently requires the use of potentially hazardous chemicals and reagents.
- Must be able to lift up to 30 pounds.
Additional Information :
Position is a full time MondayFriday 85 p.m. with overtime as needed. This position will require rotating weekend work. Candidates within commutable distance to Petaluma CA are encouraged to apply.
Compensation: $25/hr
Excellent full time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins USA BioPharma Services is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.
Remote Work :
No
Employment Type :
Fulltime