Position Summary The Quality Specialist is responsible for performing physical inspection of card batches on the production floor, supports quality walkthroughs of production areas and changeovers between batches (as applicable), and supports preperation of performance testing facilitated through microbiological laboratories.
Primary Duties
- Utilize AQL sampling guidance to inspect cards, pouches, and cartons for physical anomalies or rejects.
- May support containment of quarentined or rejected materials.
- Supports nonconformance investigations using Root Cause Analysis tools (i.e. 5 WHYS, 5M+E, Is/Is Not, etc.) as required.
- Perform walk-throughs to support technicians in comments, quality decisions, and procedure questions.
- Implements and completes continuous improvement projects as required.
- Collaborate with Final QC lab and multiple department bodies for card inspection results.
- Perform all work in compliance with company quality procedures and standards.
- Perform other duties as assigned.
Qualifications Required Education, Training and Experience
- High School Diploma, GED or equivalent
- 3+ years of related experience in an FDA manufacturing environment and/or quality manufacturing
Preferred Education, Training and Experience
- Bachelor's degree
- Experience working in a GMP environment
- Familiarity with relevant domestic and international regulations and industry standards (e.g. ISO, FDA QSR).
- Prior knowledge of MES, SPC, or SAP a plus
Knowledge, Skills, and Abilities (KSAs)
- Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
- Written Communications - including the ability to communicate technical data in written form
- Effective verbal communication skills
- Participate in a way that enhances team performance and cohesion.
- Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel
- Intermediate: applies skills independently in most situations; handles moderately complex tasks with occasional guidance
Supervisory Responsibilities (Summary) This position has no direct or indirect supervisory responsibilities. The role operates independently on operational and tactical decisions affecting immediate outcomes and daily team performance, while strategic decisions that influence future direction, sustainability, and alignment with bioMérieux's mission require supervisory review and approval.
Supplemental Data (Summary) Makes operational or tactical decisions affecting immediate outcomes and daily team performance with little-to-no supervisory review.
Strategic decisions influencing future direction, sustainability, and alignment with bioMérieux's mission require supervisory review and approval.
Working Conditions (Summary)
- Ability to remain in stationary position, either sitting or standing, for prolonged periods.
- Ability to wear PPE correctly most of the day.
- Ability to operate heavy machinery.
- Ability to adjust or move objects up to 50 pounds in all directions.
- Domestic travel required: 5% of time.
- International travel required: 0% of time.
- Total travel required: 5% of time.
Reports To: Associate Manager On Floor Support Quality Operations
The estimated salary range for this role is between $23.00 and $32.20 hourly in the state of Missouri. 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
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