Quality Assurance Specialist
Company 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.
In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description
Data Analyst responsibilities include, but are not limited to, the following:
Review laboratory data to ensure all laboratory data is maintained in accordance with prescribed specifications, procedures and Good Documentation Practices
Data review will include the evaluation of raw data as well as verification of final data integrity (i.e., calculations, adherence to SOPs, BATs, BLPs, Compendia).
Approve Master Laboratory worksheets prior to issuance to Laboratory Operations.
Represent quality on the shop floor and perform documentation accuracy and completeness checks while on the shop floor
Work closely with the assigned laboratory in a team environment to ensure timely reviews of documentation and to ensure that documentation is completed right the first time.
Work with Laboratory Operations staff and management to remediate comments and errors in documentation.
Assist Laboratory Operations in conducting investigations associated with laboratory data review.
Utilize time on the shop floor to provide Quality coaching and guidance to Laboratory Operations and technology personnel, to enable right first time testing and to ensure compliance with cGMPs and regulatory requirements.
Actively participate in the Tier process and use this forum to make concerns visible and to partner with Laboratory Operations on resolution.
Responsible for the independent auditing of laboratory data in alignment with the policies of the department, division, company and other applicable mandates. Maintain the highest level of proficiency in terms of those duties and responsibilities required of auditors.Maintain metrics and tracking associated with these documentation reviews.
Complete the remediation activities for all data reviews, to ensure errors are appropriately corrected and documented following departmental and site procedures.
Perform review and approval of qualification documents as needed.
Ensure that laboratory data is in compliance with cGMPs, GLPs and departmental procedures and assay methods and is of the highest integrity, quality and accuracy.
Responsible for approval of Master Laboratory Worksheets prior to issuance to floor for use.
Responsible for issuance of new and reconciliation of completed laboratory worksheets
Foster a customer service attitude within Laboratory Operations
Provide support to Regulatory Agency inspections as needed.
Qualifications
Qualifications
The ideal candidate would possess:
Bachelors Degree in life science, scientific discipline or engineering. MS in life science or engineering.
In lieu of a Life Sciences or other Bachelor's degree, equivalent direct experience of 6 years of working in a GMP environment, direct experience with documentation review and / or control, or prior experience supporting Regulatory Agency inspections is required.
Minimum 1-2 years 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.
General laboratory skills and background knowledge
Experience using Microsoft Office programs such as Word and Excel
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
Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.
Demonstrated analytical aptitude, critical thinking skills and problem solving skills.
Demonstrated ability to upskill / coach others.
Strong written and verbal communication skills.
Experience in pharmaceutical laboratory operations or related environment.
Additional Information
Position is full-time and permanent, Monday-Friday, 2nd shift 3pm-11pm with shift differential pay and over time as needed. Candidates currently living in a commutable distance to West Point, PAare 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.Estimated Salary: $20 to $28 per hour based on qualifications.
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.
In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description
Data Analyst responsibilities include, but are not limited to, the following:
Review laboratory data to ensure all laboratory data is maintained in accordance with prescribed specifications, procedures and Good Documentation Practices
Data review will include the evaluation of raw data as well as verification of final data integrity (i.e., calculations, adherence to SOPs, BATs, BLPs, Compendia).
Approve Master Laboratory worksheets prior to issuance to Laboratory Operations.
Represent quality on the shop floor and perform documentation accuracy and completeness checks while on the shop floor
Work closely with the assigned laboratory in a team environment to ensure timely reviews of documentation and to ensure that documentation is completed right the first time.
Work with Laboratory Operations staff and management to remediate comments and errors in documentation.
Assist Laboratory Operations in conducting investigations associated with laboratory data review.
Utilize time on the shop floor to provide Quality coaching and guidance to Laboratory Operations and technology personnel, to enable right first time testing and to ensure compliance with cGMPs and regulatory requirements.
Actively participate in the Tier process and use this forum to make concerns visible and to partner with Laboratory Operations on resolution.
Responsible for the independent auditing of laboratory data in alignment with the policies of the department, division, company and other applicable mandates. Maintain the highest level of proficiency in terms of those duties and responsibilities required of auditors.Maintain metrics and tracking associated with these documentation reviews.
Complete the remediation activities for all data reviews, to ensure errors are appropriately corrected and documented following departmental and site procedures.
Perform review and approval of qualification documents as needed.
Ensure that laboratory data is in compliance with cGMPs, GLPs and departmental procedures and assay methods and is of the highest integrity, quality and accuracy.
Responsible for approval of Master Laboratory Worksheets prior to issuance to floor for use.
Responsible for issuance of new and reconciliation of completed laboratory worksheets
Foster a customer service attitude within Laboratory Operations
Provide support to Regulatory Agency inspections as needed.
Qualifications
Qualifications
The ideal candidate would possess:
Bachelors Degree in life science, scientific discipline or engineering. MS in life science or engineering.
In lieu of a Life Sciences or other Bachelor's degree, equivalent direct experience of 6 years of working in a GMP environment, direct experience with documentation review and / or control, or prior experience supporting Regulatory Agency inspections is required.
Minimum 1-2 years 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.
General laboratory skills and background knowledge
Experience using Microsoft Office programs such as Word and Excel
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
Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.
Demonstrated analytical aptitude, critical thinking skills and problem solving skills.
Demonstrated ability to upskill / coach others.
Strong written and verbal communication skills.
Experience in pharmaceutical laboratory operations or related environment.
Additional Information
Position is full-time and permanent, Monday-Friday, 2nd shift 3pm-11pm with shift differential pay and over time as needed. Candidates currently living in a commutable distance to West Point, PAare 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.Estimated Salary: $20 to $28 per hour based on qualifications.
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