Aseptic Manufacturing Quality Technician

Position Summary

The Quality Technician is responsible for supporting site quality functions and ensuring compliance with applicable regulatory and quality standards, including ISO 13485, MDSAP, FDA, and EU MDR requirements. This role primarily supports aseptic manufacturing operations through in-process inspections, environmental monitoring, quality testing, and product acceptance activities. The Quality Technician assists with identifying and documenting nonconformances, conducting investigations, reviewing manufacturing records, supporting product release activities, and maintaining calibration and monitoring programs to ensure product quality and compliance.

What You'll Do

• Assists in production line Quality investigations and associated problem-solving activities.
• May coordinate and conduct in-process and final QC product acceptance testing, depending on facility.
• Investigates production line stoppages to identify corrective actions.
• Identifies and documents product and process non-conformances.
• Participates on a Material Review Board to review and process non-conformance reports.
• Reviews DHR's and supports batch record release.
• Enters and retrieves Quality data from local and global systems.
• Performs site calibration activities and recordkeeping.
• Executes environmental monitoring processes and recordkeeping.
• Verifies calculations, dose ranges, dosimeter placements and special instructions prior to processing and part of final product release.
• Will make decisions regarding the acceptability of raw materials, work in process and finished products.
• Identify opportunities for improvement and non-conformances.
• Propose potential solutions to site management and work with the appropriate individuals to implement the agreed upon improvement.

Required Skills, Abilities, and Experience

• HS Diploma/GED + three (3) years of experience in a manufacturing or repair environment or other technical production tasks.
• Associates + Minimum of one (1) year of experience in a manufacturing or repair environment or other technical production tasks.
• Experience with mathematical skills including ratios, proportions and basic algebra.
• Ability to work in a fast-paced environment with strict deadlines.
• Generate detailed, high-quality documentation.
• Work with others in analyzing and solving technical problems.
• Work in a professional manner to support team actions.
• Effectively manage work tasks.
• PC experience and familiarity of common desktop applications including Excel and Word.
• Must pass gowning certification through STERIS.

Preferred

• Previous work expereince in a regulated industry, preferably: ISO 13485, FDA or similar.
• Experience working in an environment with aseptic gowning and/or current certification.
• Strong GDP (good documenting processes) in a 5S/Lean manufacturing environment.
• Experience cross training between aseptic and chemical environment.

Physical Demands

• Lifting, pushing, pulling between 25 - 50lbs.
• Bending, walking, standing, sitting, typing, hand manipulation, and visual acuity.
• Able to stand/balance on one foot (required for aseptic gowning).

What STERIS Offers

• Market Competitive Pay
• Extensive Paid Time Off and (9) added holidays
• Excellent Healthcare, Dental and Vision Benefits
• Long/Short Term disability coverage
• 401(k) with company match
• Tuition Reimbursement and continued educations programs
• Additional add-on benefits/discounts for programs such as Pet Insurance
• Opportunities for advancement and stable long-term career

PAY RANGE FOR THIS OPPORTUNITY IS $20.84 - $25.75. THIS POSITION IS ELIGIBLE FOR BONUS PARTICIPATION. MINIMUM PAY RATES OFFERED WILL COMPLY WITH COUNTY/CITY MINIMUMS, IF HIGHER THAN RANGE LISTED. PAY RATES ARE BASED ON A NUMBER OF FACTORS, INCLUDING BUT NOT LIMITED TO LOCAL LABOR MARKET COSTS, YEARS OF RELEVANT EXPERIENCE, EDUCATION, PROFESSIONAL CERTIFICATIONS, FOREIGN LANGUAGE FLUENCY, ETC.

STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.