Job Description

_ Data Analyst responsibilities include, but are not limited to, the following:_

• Review laboratory data to ensure all laboratory data is maintained in accordance with prescribed specifications, procedures and Good Documentation Practices
• Data review will include the evaluation of raw data as well as verification of final data integrity (i.e., calculations, adherence to SOPs, BATs, BLPs, Compendia).
• Approve Master Laboratory worksheets prior to issuance to Laboratory Operations.
• Represent quality on the shop floor and perform documentation accuracy and completeness checks while on the shop floor
• Work closely with the assigned laboratory in a team environment to ensure timely reviews of documentation and to ensure that documentation is completed right the first time.
• Work with Laboratory Operations staff and management to remediate comments and errors in documentation.
• Assist Laboratory Operations in conducting investigations associated with laboratory data review.
• Utilize time on the shop floor to provide Quality coaching and guidance to Laboratory Operations and technology personnel, to enable right first time testing and to ensure compliance with cGMPs and regulatory requirements.
• Actively participate in the Tier process and use this forum to make concerns visible and to partner with Laboratory Operations on resolution.
• Responsible for the independent auditing of laboratory data in alignment with the policies of the department, division, company and other applicable mandates. Maintain the highest level of proficiency in terms of those duties and responsibilities required of auditors.
  • Maintain metrics and tracking associated with these documentation reviews.
  • Complete the remediation activities for all data reviews, to ensure errors are appropriately corrected and documented following departmental and site procedures.
• Perform review and approval of qualification documents as needed.
• Ensure that laboratory data is in compliance with cGMPs, GLPs and departmental procedures and assay methods and is of the highest integrity, quality and accuracy.
• Responsible for approval of Master Laboratory Worksheets prior to issuance to floor for use.
• Responsible for issuance of new and reconciliation of completed laboratory worksheets
• Foster a customer service attitude within Laboratory Operations
• Provide support to Regulatory Agency inspections as needed.

Qualifications

_ Qualifications_

The ideal candidate would possess:

• Bachelors Degree in life science, scientific discipline or engineering. MS in life science or engineering.
• In lieu of a Life Sciences or other Bachelor’s degree, equivalent direct experience of 6 years of working in a GMP environment, direct experience with documentation review and / or control, or prior experience supporting Regulatory Agency inspections is required.
• Minimum 1-2 years experience in GMP Manufacturing environment, Pharmaceutical / Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.
• General laboratory skills and background knowledge
• Experience using Microsoft Office programs such as Word and Excel
• Strong computer, scientific, 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
• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.
• Demonstrated analytical aptitude, critical thinking skills and problem solving skills.
• Demonstrated ability to upskill / coach others.
• Strong written and verbal communication skills.
• Experience in pharmaceutical laboratory operations or related environment.

Additional Information

Position is full-time and permanent, Monday-Friday, 8am-5pm with over time as needed. Candidates currently living in a commutable distance to West Point ** _ , PA_** ** __** are encouraged to apply. On-site work is expected in order to be effective in this role.

** What we offer:**

• 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
• Yearly goal-based bonus & eligibility for merit-based increases

Eurofins Lancaster Laboratories Professional Scientific Services® (PSS) is a global, award-winning insourcing solution that places our people at our clients’ site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client’s quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.