Senior Quality Specialist

Job Description

Applies GMP/GLP/ISO IEC 17025 in all areas of responsibility, as appropriate
Performs internal quality assurance audits
Reviews client or agency documents and identify requirements outside our usual practices, communicates to technical operations, assists with implementing appropriate changes
Reviews and approves SOPs
Keeps abreast of regulatory or industry quality assurance (QA) requirements, consults with clients or regulatory authorities regarding any special QA requirements they may have, assists technical operations with application and interpretations
Provides information and revision support for updating company publications including quality policy manuals, company web site, and newsletters
Identifies and drives system improvements, both within the department and for laboratory operations; determines the most effective way to accomplish a goal or strategy; suggests improvements to maximize quality and productivity
Demonstrates skill in using the computer to access information, perform job functions (e.g., spreadsheets, power point), and prepare other reports
Performs data review (analytical, validation, investigations), reviews for compliance and identifies issues, provides options for resolution
Reviews QC data and non-conformance issues for assigned technical groups, evaluates for trends or patterns
Investigates and documents QA, method, and regulatory deficiencies within the lab; takes investigation to next level when needed; diagnoses and solves problems independently
Implements and documents computer program changes, reviews computer system documents, provides 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

Additional Information - Eurofins USA BioPharma Services

• Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.