GMP Data Review Specialist

Eurofins BioPharma Product Testing North America; Lancaster (Lancaster County); On-site; USD 50,000 - 70,000; Full time

Benefits offered by this job

Comprehensive medical coverage

Dental and vision options

Paid vacation and holidays

401(k) with company match

Job summary

Eurofins BioPharma Product Testing North America is seeking a high-quality candidate for a full-time position focused on ensuring data integrity and GMP compliance. This role involves reviewing lab documentation and developing techniques relevant to the assays performed.

The ideal applicant should have a degree in molecular biology and at least one year of lab experience. Responsibilities will include the collaboration in a team to meet testing requirements.

The position offers a competitive benefits package including comprehensive medical coverage and a 401(k) plan.

Qualifications

• Bachelor's degree in molecular/cellular biology or equivalent experience required.
• 1-2 years of experience in molecular and/or cell biology, especially in real-time PCR and ddPCR.
• Strong computer skills along with attention to detail.

Responsibilities

• Ensure data quality and adherence to GMP requirements.
• Review laboratory documentation for accuracy and clarity.
• Document work as required for compliance.

Skills

Real-time PCR

ddPCR

ELISA

Nucleic acids sequencing

GMP compliance

Communication skills

Organizational skills

Education

Bachelor’s degree in molecular/cellular biology or related field

Job description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

Job Description

*THIS IS NOT A DATA SCIENCE POSITION*

Employee Responsibilities:

• Ensure that the client receives high quality data and reports that adhere to client and good manufacturing process (GMP) requirements.
• Reviewing laboratory documentation for accuracy, consistency, and clarity.

• Gain a technical understanding of the techniques for the assays in which review is being performed
  
  

• Begin to gain industry knowledge of the testing being completed within the department
  
  

• Document work as required for GMP compliance
  
  
  
  

Qualifications

The Ideal Candidate would possess:

• One to two years experience in molecular and/or cell biology, mainly real-time PCR, ddPCR, ELISA, cell based plate reader, and nucleic acids sequencing.
  
  

• GMP experience

• 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 Qualifications:

• Bachelor’s degree in molecular/cellular biology or other related degree concentration, or equivalent directly-related experience.
  
  

• At least one to two years hands on experience in a molecular/cell biology laboratory; industry and/or contract testing experience desired
  
  

• Familiarity or experience with GMP setting highly preferred
  
  

• Authorization to work in the United States indefinitely without restriction or sponsorship
  
  
  
  

Additional Information

Position is Full-time, Monday-Friday, 8:00 a.m.-4:00 p.m., with overtime as needed. Candidates currently living within a commutable distance of Lancaster, Pennsylvania 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 USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.