A Biochemistry Senior Investigator is responsible for:-conduction, and writing of complex GMP laboratory investigations;-collaborating with technical and support staff to write, author and assist in implementation of effective Corrective Action/ Preventive Actions (CAPA);-support management by assisting and addressing internal and external audits; utilize all laboratory systems to accomplish these tasks.-Works closely with QA to ensure compliance to GMP requirements. Essential Duties and Respons... more details
Job Description
A Biochemistry Senior Investigator is responsible for:
-conduction, and writing of complex GMP laboratory investigations;
-collaborating with technical and support staff to write, author and assist in implementation of effective Corrective Action/Preventive Actions (CAPA);
-support management by assisting and addressing internal and external audits; utilize all laboratory systems to accomplish these tasks.
-Works closely with QA to ensure compliance to GMP requirements.
Essential Duties and Responsibilities:
Applies GMP/GLP in all areas of responsibility, as appropriate
Applies the highest quality standard in all areas of responsibility
Demonstrates and promotes the company vision
Demonstrates strong client service skills, teamwork, and collaboration
Proactively plans and multitasks to maximize productivity
Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
Regular attendance and punctuality
Assists Biochemistry Management with complex GMP laboratory investigations such as Out of Specifications, Out of Trend and Client Complaints.
Independently initiate, conduct, write and complete routine investigations in a timely manner.
Executes human error analysis.
Complete and implement effective Corrective Action\Preventive Actions (CAPA) to minimize repeat errors.
Proficiently utlizes all laboratory systems such as laboratory information systems (eLIMS) and data collection systems such as Empower.
Assist management with internal audits and laboratory walk through findings as well as client audits.
Managing documentation in support of routine investigations and corrective action follow up.
Communicates effectively with client staff members
Conducts all activities in a safe and efficient manner
Performs other duties as assigned
Qualifications
Must have:
Bachelor's degree in science-related field with three years pharmaceutical experience including some investigation participation.
Authorized to work in the US without need of visa or sponsership.
Additional Information
Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Lancaster, PA 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
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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