Senior Quality Specialist
On-siteLancaster, Pennsylvania, United States
Job Summary
Conduct internal quality assurance audits, review client documents for non-standard requirements, and approve standard operating procedures. Perform data review and investigate QA, method, and regulatory deficiencies within the lab, diagnosing and solving problems independently. Keep abreast of regulatory quality assurance requirements, consult with clients or authorities on special needs, and drive system improvements for department and laboratory operations. Provide revision support for updating company publications including quality policy manuals and newsletters. This role requires a Bachelor's degree in a science-related field and minimum three years of laboratory experience with knowledge of regulatory requirements. Full-time position in Lancaster, Pennsylvania, Monday-Friday, 8 a.m.-5 p.m.
Required Qualifications
- 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
- 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
- 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
- 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
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