Eurofins Lancaster Laboratories

Senior Quality Specialist: Medical Device

Eurofins Lancaster Laboratories • $80K — $95K *
Lancaster, PA 17603In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Strong computer, scientific, quality orientation, and organizational skills
  • Excellent communication skills, both oral and written
  • Ability to work independently and collaboratively in a team
  • Self-motivated with a positive attitude and adaptability
  • Proficient in word processing, spreadsheets, PowerPoint, and databases
  • Previous experience with GMP, Root Cause Analysis, and technical writing

Responsibilities

  • Apply GMP/GLP/ISO IEC 17025 compliance in all relevant areas
  • Perform internal quality assurance audits to ensure adherence to standards
  • Review client documents to identify unique QA requirements and assist technical operations in implementation
  • Review and approve Standard Operating Procedures (SOPs)
  • Stay updated on regulatory QA requirements and consult with clients regarding special needs
  • Support the updating of company publications related to quality management
  • Identify and drive system improvements to enhance quality and productivity

Benefits

  • Comprehensive medical coverage, dental, and vision options
  • Life and disability insurance
  • 401(k) with company match
  • Paid vacation and holidays
Full Job Description
Job Description
  • Applies GMP/GLP/ISO IEC 17025 in all areas of responsibility, as appropriate
  • Perform internal quality assurance audits
  • Review client or agency documents and identify requirements outside our usual practices, communicate to technical operations, assist with implementing appropriate changes
  • Perform review and approval of SOP's
  • Keep abreast of regulatory or industry quality assurance (QA) requirements, consult with clients or regulatory authorities regarding any special QA requirements they may have, assist technical operations with application and interpretations
  • Provide information and revision support for updating company publications including quality policy manuals, company web site, and newsletters
  • Identify and drive system improvements, both within the department and for laboratory operations; determine the most effective way to accomplish a goal or strategy; suggest improvements to maximize quality and productivity
  • Demonstrate skill in using the computer to access information, perform job functions (e.g., spreadsheets, power point), and prepare other reports
  • Perform data review (analytical, validation, investigations), review for compliance and identify issues, provide options for resolution
  • Review QC data and non-conformance issues for assigned technical groups, evaluate for trends or patterns
  • Investigate and document QA, method, and regulatory deficiencies within the lab; take investigation to next level when needed; diagnose and solve problems independently
  • Implement and document computer program changes, review computer system documents, provide feedback to meet regulatory and industry expectations


Qualifications
  • Strong computer, scientific, quality orientation, and organizational skills
  • Excellent communication (oral and written) and attention to detail
  • Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
  • Word processing, spreadsheets, PowerPoint, and database experience
  • Previous GMP, Root Cause Analysis, and technical writing experience

Minimum Qualifications:
  • Bachelor's degree in a science-related field or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
  • Minimum three years of laboratory experience with knowledge of regulatory requirements
  • Authorization to work in the United States indefinitely without restriction or sponsorship


Additional Information

Position is Full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed. Candidates currently living within a commutable distance of Lancaster, Pennsylvania are encouraged to apply.

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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About Eurofins Lancaster Laboratories

Eurofins Lancaster Laboratories is a leading contract research organization (CRO) providing analytical, research and testing services to clients in the pharmaceutical, biopharmaceutical, biotechnology, crop protection, chemical, food, environmental and consumer products industries. The company was founded in 1961 and has grown to become one of the largest CROs in the world, with over 50 locations in 20 countries. Eurofins Lancaster Laboratories is part of the Eurofins Scientific Group, a global leader in bioanalytical testing and laboratory services. The company's services include method development and validation, stability testing, quality control testing, and regulatory compliance support.
Learn more about Eurofins Lancaster Laboratories
Size
12,000 employees
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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