Jobs · Quality Assurance · Pennsylvania

Quality Manager

Eurofins Viracor BioPharma Services · Lancaster, PA · 2 days ago
Quality AssuranceFull-time

About the Role

Shift: Monday-Friday, 10:30am-7pm (Additional hours as needed). The Local Quality Manager will be responsible for supporting the operational and technical supervisor in ensuring timelines and quality measures are met and technicians are on task. This position may have authority over local quality specialist(s) for delegated quality tasks.

Essential Duties and Responsibilities

  • Demonstrates and promotes the company vision
  • Regular attendance and punctuality
  • Reads, understands and follows management system requirements as relevant to responsibilities, including but not limited to requirements found in the Quality Manual, SOPs, Local Work Instructions and Methods which in turn ensures compliance with ISO/IEC 17025/AOAC ALACC requirements and relevant government regulatory requirements
  • Reviews and distributes new/revised controlled documents and ensures the proper maintenance/disposal of superseded SOPs
  • Acts as a resource for laboratory personnel for correct application and interpretation of internal quality documents
  • Ensures staff is aware and trained on documents and requirements relevant to their responsibilities and reviews employee training records on a regular basis to ensure training records are properly completed and on-file
  • Ensures daily process controls for enumeration and pathogen testing are prepared with client samples and evaluates data to ensure it meets pre-defined acceptance criteria
  • Conducts annual self-audit, conducts or coordinates monthly method audits, and generates audit reports including findings
  • Ensures non-conformances and complaints are identified and documented and that timeliness requirements are met. Monitors non-conformances, root cause analysis, and complaint resolutions for trends. Assists in root cause analysis and corrective action efforts
  • Ensures equipment is properly qualified and maintained. Maintains equipment list and calibration schedule and ensures that calibrations are performed in a timely manner. Ensures the qualifications of contracted calibration services
  • Verifies results and submits results, either electronically or in hard copy, to the appropriate personnel for transmission, in a timely manner
  • Maintains schedule and participation in proficiency testing programs with technical management
  • Maintain a perpetual state of readiness and willingness to respond to the queries and needs of clients, staff, and co-workers
  • Coordinates the monitoring and review of the performance of quality critical suppliers; maintains a list of currently approved suppliers
  • Conducts Quality Management Review meeting at least once per year in cooperation with laboratory management
  • Accompany auditors (e.g. ISO quality inspectors) during audits of the laboratory and coordinates responses to audit findings
  • Maintain cooperative working relationships with all company employees. Communicate orally and in writing to co-workers. This includes "intra" and "inter" departmental employees
  • Adhere to all health, safety, and environmental regulations relative to assigned analytical work; maintain and assist others in maintaining a clean, safe work environment
  • Performs other duties as assigned

Qualifications

  • Bachelor's degree in science or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
  • Willing to work overtime, weekends, and holidays as needed
  • Authorization to work in the United States indefinitely without restriction or sponsorship

Preferred Qualifications

  • Bachelor's degree in Food Science or Microbiology preferred

Skills and Abilities

  • Prefer experience or coursework in laboratory procedures, data analysis, computer operations, mathematics, and technical/business writing
  • Previous experience in a production style laboratory preferred
  • Prior in-depth experience working in an ISO 17025 accredited testing laboratory and with QC/QA programs an important advantage
  • A strong understanding of food microbiology and corrective action investigation is strongly desired
  • Excellent interpersonal and organizational skills with excellent attention to detail
  • Excellent communication skills
  • Self-motivated and driven critical thinker able to work in high pace and rapidly changing environment
  • Responsive problem solver and action oriented

Benefits

  • 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

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