GMP Lab Specialist

2 weeks ago

Worcester Township PA USA, United States Lancaster Laboratories Full time
Job Title: GMP Lab Specialist

Join Lancaster Laboratories as a GMP Lab Specialist and contribute to the success of our clients by providing high-quality laboratory services.

Job Summary

We are seeking a highly skilled and detail-oriented GMP Lab Specialist to join our team. As a GMP Lab Specialist, you will be responsible for ensuring the accuracy and integrity of laboratory data, maintaining compliance with regulatory requirements, and providing exceptional customer service.

Key Responsibilities
  • Perform second scientist and second person review as required
  • Train and operate as a key SME in Labware LIMS inventory systems
  • Ensure all work is compliant with all regulatory expectations
  • Conform to current Good Manufacturing Practices (cGMP) as they apply to the functions of the position
  • Perform Quarterly Equipment and logbook review
  • Perform Review of Equipment Temperature Data in OpenLab, DeltaV, or BAS PI
Requirements
  • Strong scientific and organizational skills
  • Proficiency in MS Project and MS Visio
  • Excellent communication (oral and written) skills with both English and ESL speakers
  • High level of attention to detail, in particular with the preparation of GMP documentation and the work associated with that documentation
  • Ability to work independently and on a team
  • Highly self-motivated, expected to contribute to the work and take ownership of projects
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
  • Experience in classical biochemical assays and molecular biological techniques
  • GMP experience
  • Experience in statistical analysis using with JMP, Minitab, or Excel
  • Technical writing experience
  • Experience with regulatory audits
Qualifications
  • Bachelor's degree in biology, chemistry, or other related degree concentration with 2-3 years of related experience, or Master's degree with 0-1 year experience
  • Authorization to work in the United States indefinitely without restriction or sponsorship
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

Lancaster Laboratories 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 Lancaster Laboratories, please explore our website www.eurofinsus.com.

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

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