Perform routine and non-routine microbial analyses of raw materials, in-process materials, finished products, and product stability samples. Environmental monitoring of equipment, water systems, and workspace. Perform preservative efficacy testing on product formulas. Accurately record and review laboratory data and documentation. Participate in laboratory investigations of OOS or aberrant results. Troubleshoot equipment and method related problems. Perform validation, calibration, and maintenance on laboratory equipment. Perform test method validations.
Requirements
Responsibilities
- Perform analyses on samples according to SOP's and U.S. Pharmacopoeias using pour plate and rapid micro testing methods.
- Accurately record and review laboratory data and documentation according to SOP's and cGMP.
- Perform validation, calibration, and maintenance of laboratory equipment.
- Prepare and review SOP's.
- Perform test method development and validation.
- Take microbiological samples for environmental monitoring quarterly.
- Prepare and read swabs for microbiological testing of production equipment.
- Sampling and monitoring of water systems and perform pH, conductivity, and microbiological tests on those samples.
- Maintain laboratory supplies, media, and cleanliness.
- Take part in investigations of OOS or aberrant results.
- Prepare and run Challenge Testing/PET.
- Perform species identification of product/raw material contaminants per U.S. Pharmacopoeias.
- Ability to delegate, assign, encourage, develop, train and coach colleagues of varying levels of experience.
- Proper handling and disposal of biohazardous laboratory waste.
- Ability to lead investigations of microbiological contamination, including RCA, CAPA, and risk assessment according to contaminant identity and growth concentration.
- Ability to effectively manage and run a laboratory independently.
- Regularly update QC Manager and management teams on quality initiatives and progress.
- Oversee the equipment cleaning and sanitation process and implement new equipment and techniques to improve the effectiveness of the procedures.
Required Skills/Abilities - Knowledge of laboratory equipment set-up and operation, common laboratory techniques, and safe chemical handling.
- Knowledge of ISO 9001:2015, FDA, and other regulatory compliance.
- Knowledge of U.S. Pharmacopoeia test organisms and maintenance of live microbiological cultures.
- Proficient knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 210 & 211
- Excellent written, verbal, and interpersonal communication skills.
- Ability to prioritize multiple responsibilities and manage deadlines accordingly.
- Communicate effectively with all members of organization and all levels of management.
- Exceptional attention to detail and high level of accuracy & organization.
- Ability to work independently with minimal supervision in a fast-paced environment.
- Ability to adapt quickly to changing policies and procedures.
- Ability to speak, read and write English.
- Proficient knowledge of computers and Microsoft Office.
- Sustain and promote a safe work environment and mentor/coach team members towards toward a "best in class" high performance organization.
Required Education and Experience - BS or equivalent experience in Microbiology, Biology, or related field.
- 1-3 years in a Microbiological laboratory setting.
Preferred Education and Experience - Knowledge of cGMP's
- Knowledge of U.S. Pharmacopoeias
EEO Statement Bell International Laboratories provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
