What are the responsibilities and job description for the Associate QC Scientist position at bioMérieux?
bioMérieux is a pioneering force in the medical microbiology device industry. Our cutting-edge technologies have been transforming healthcare and improving patient outcomes.
We are seeking an Associate QC Scientist. They will work in a cGMP environment performing quality control testing for commercial diagnostics products. Responsibilities include Incoming QC Inspection of components and raw materials and testing of products to approved specifications according to approved processes and procedures. Interdepartmental collaboration to support production schedule, elevate quality issues, and ensure quality of production batches. Provides quality support in the areas of change control, nonconformance and deviation management, continual improvement, quality trends, quality costs, documentation control to ensure compliance with the regulatory requirements. Performs all duties using quality mindset and safety conscious practices.
Primary Duties:
- Conducts routine QC testing of incoming raw material, finished goods, and stability products.
- Document results, issues, and other relevant information using good documentation practices (GDP) under the site Quality Management System.
- Reviews production batch records and QC test results for accuracy, completeness, and GDP.
- Supports and executes protocols for analytical test methods and aids in the transfer of methods to QC.
- Perform final inspections of completed medical devices and accessories, including the detailed review of the Device History Record package to confirm the completeness and accuracy of records.
- Participates in regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of manufacturing quality. Also participates in the site Internal audit and compliance review programs.
- Supports the effective closure of complaint investigations, nonconformance reports, Cause Investigations, and CAPA in a timely manner.
- Analyzes, prepares, and communicates data findings, trends, non-conformances, and deviations.
- Maintain lab equipment compliance by ensuring preventative maintenance and calibrations are completed on time.
- Supports environmental monitoring of production spaces.
- Run instrumentation including, but not limited to UV-Vis and FTIR spectrophotometers, and microbiological diagnostic equipment.
- Maintains inventory and orders lab supplies as needed.
- Practices good lab safety according to OSHA/EHS regulations and Good Laboratory Practice (GLP), as well as other applicable regulations.
- Updates QC procedures and/or specifications as needed.
- Perform all work in compliance with company quality procedures and standards.
- Performs other duties as assigned.
Minimum Qualifications:
- BS in biology, chemistry or related scientific field
- Minimum of 0-1 years’ relevant laboratory experience.
- Medical Device or other FDA regulated industry experience is preferred.
- Must possess working knowledge of good laboratory practices, GMP, and antibiotic/microorganism interactions.
- Experience working with hazardous chemicals and microorganisms.
The estimated hourly range for this role based in California is between $34.85 - 46.58. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.
In addition, bioMérieux offers a competitive Total Rewards package that may include:
· A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
· Company-Provided Life and Accidental Death Insurance
· Short and Long-Term Disability Insurance
· Retirement Plan including a generous non-discretionary employer contribution and employer match.
· Adoption Assistance
· Wellness Programs
· Employee Assistance Program
· Commuter Benefits
· Various voluntary benefit offerings
· Discount programs
· Parental leaves
Salary : $35 - $47
