Investigations author responsibilities include, but are not limited to, the following :Operate as part of a LVV technical support team. Investigate laboratory deviations and errors to determine root cause and ensure Corrective and Preventative Actions (CAPAs) are implemented. Review data audits. Author reports as needed. Ensure investigations adhere to the compliance-driven timeline. Ensuring compliance in the laboratory in accordance with cGMPs, and GL - Ps, international regulations guidelines... more details
Job Description
Investigations author responsibilities include, but are not limited to, the following:
Operate as part of a LVV technical support team
Investigate laboratory deviations and errors to determine root cause and ensure Corrective and Preventative Actions (CAPAs) are implemented
Review data audits
Author reports as needed
Ensure investigations adhere to the compliance-driven timeline
Ensuring compliance in the laboratory in accordance with cGMPs, and GLPs, international regulations guidelines, and policies/procedures.
Support key projects for Laboratory Operations aimed at elevating the compliance, assay robustness, and performance of the laboratories within their responsibility.
Support laboratory investigations including identification of root cause, identification and implementation of corrective and preventative actions, and authoring the final investigation report
Potential support required in technical oversight of Virology quality control assays
Potential support in providing analytical change management support for Virology testing labs
Ensuring compliance in the laboratory in accordance with cGMPs, and GLPs, regulation, and policies/procedures
Potential support in coordination of analytical changes for Virology testing labs
Support key commitments for analytical change within Laboratory Operations aimed at elevating the compliance, assay robustness, and performance of the laboratories within their responsibility
Strong computer, scientific, and organizational skills
Excellent communication (oral and written)
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
Ability to learn quickly, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Attentiveness to detail
Experience with GMP documentation practices and a strong understanding of GMP practices in the instructions, and comply with company policies
Technical writing expertise preferred
Industry deviation Management experience preferred
Root Cause Analysis expertise preferred
Basic Minimum Qualifications:
Degree in Biology, Cell Biology or Microbiology is preferred OR M.S. degree in life science, biochemistry, scientific discipline or engineering
5+ Yeas in Science industry experience
Experience Troubleshooting Laboratory Deviations
Experience in Technical Writing
Authorization to work in the United States indefinitely without restriction or sponsorship
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.
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