- Administrative support in reconciliation of controlled worksheets.
- Experience working in dynamic environments where flexibility is essential
- Assist different LOCV departments on an ad-hoc basis to ensure smooth functioning of operations
- Independent auditing of laboratory data to ensure that regulatory compliance is maintained.
- Maintain the highest level of proficiency in terms of those duties and responsibilities required of auditors.
- Foster a customer service attitude within and among laboratory personnel.
- Ensure the laboratory data is in compliance with cGMPS, GLPs, and departmental procedures and assay methods and is of the highest integrity, quality and accuracy.
- Review laboratory notebooks, logbooks, and CTU records to ensure compliance to data integrity and accuracy.
- Complete the remediation activities of all data reviews to ensure errors are appropriately corrected and documented following departmental and site procedures.
- 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, etc.).
- Works with laboratory staff and management to remediate comments and errors in documentation.
- May assist in conducting investigations associated with laboratory data review.
The ideal candidate would possess:
- Flexibility is a core attribute we value in this role, as it often involves responding to unexpected challenges or changes in workload.
- Offer support across different departments within lab operations to ensure seamless coordination and collaboration
- 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
- Minimum 1 – 2 years’ experience in Quality, Regulatory, or related experience
Qualifications
Basic Minimum Qualifications:
- Bachelor’s degree in biology, virology, biochemistry or chemistry.
- One year in a GMP, GLP/GDP environment.
- Authorization to work in the United States indefinitely without restriction or sponsorship
- Position is full-time and permanent, Monday-Friday, 2nd shift 3pm-11pm, with over time as needed and rotation of weekend support (~4 weekends per year). Candidates currently living in a commutable distance to West Point, PA are encouraged to apply.
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
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.
