Eurofins Lancaster Laboratories PSS is searchi ng for a Technical Writer in We st Point, PA.
Technical Writer responsibilities include, but are not limited to, the following :
- Operate as part of a deviations management 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
- Providing quality and technical support to a team of Laboratory Managers, Data Analysts and Laboratory Technicians.
- Ensuring compliance in the laboratory in accordance with cGMPs, and GLPs, international regulations guidelines, and policies/procedures.
- Direct technical support of the assays performed in the biochemistry, virology and/or chemistry laboratories
- 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
The ideal candidate would possess :
•Laboratory background (Biochem, Micro, Chem, Virology, etc.)
•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
Basic Minimum Qualifications :
• Degree in Chemistry, Biology, or Biochemistry is preferred OR M.S. degree in life science, biochemistry, scientific discipline or engineering
• For candidates with a Bachelor's degree, a minimum of 3 years of 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
•Experience Troubleshooting Laboratory Deviations
•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 West Point, Pennsylvania are encouraged to apply.
As a Eurofins Lancaster Labs employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options.
To learn more about Eurofins, please explore our website www.eurofinsus.com . Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer