Senior Quality Specialist: Lab Compliance Chemistry

Eurofins BioPharma Product Testing North America; Lancaster (Lancaster County); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Comprehensive medical coverage

Life and disability insurance

401(k) with company match

Paid holidays and vacation

Dental and vision options

Job summary

Eurofins USA BioPharma Services in Lancaster, PA, seeks a QA/QC Analyst to apply GMP/GLP, monitor lab compliance, and support internal audits. You will review instrument qualifications, verify data, and help resolve deviations.

Requirements include a Bachelor's degree in Chemistry or related science, 3+ years of pharmaceutical lab experience, and knowledge of regulatory requirements. Excellent organizational skills and attention to detail are essential.

Qualifications

• GMP/GLP principles and quality systems experience.
• Audit experience in a regulated lab environment.
• Knowledge of regulatory requirements applicable to pharma QA/QC.

Responsibilities

• Apply GMP/GLP in all areas of responsibility and support audits.
• Review instrument qualifications and data integrity; close deviations.
• Track quality metrics and train staff to reduce rework.

Skills

GMP/GLP knowledge

Audit experience

Regulatory compliance

Quality metrics analysis

Education

Bachelor's degree in Chemistry or related science

Tools

LIMS software

MS Excel

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 Organization 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 Organizations. It also has a rapidly developing presence in highly specialized 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 decentralized 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 Organization 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 Organizations. It also has a rapidly developing presence in highly specialized 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 decentralized 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

• Applies GMP/GLP in all areas of responsibility, as appropriate
• Monitor laboratory compliance with respect to expired reagents, reagent labeling, lab cleanliness, training records, PPE adherence, and other cGXP items, as needed to help minimize laboratory audit findings.
• Perform/Support Internal audits, as well as help, implement the resolution of internal/external audit findings
• Review Instrument qualifications to ensure that work is performed as per the procedure
• Review and verify invalid data and system suitability failures
• Review and close Exceptions under Non-Routine Events, System Suitability Failure, and Deviations
• Approve Analytical Method/Protocol/SMIS/Client Parameter per QA procedure
• Track and Analyze quality metrics (exception rate, rejection rate etc) and train laboratory personnel, as needed, to help reduce/eliminate rework
• Support other QA compliance-related activities, as needed
• Diagnose problems, solve simple problems, and suggest solutions to complex problems in the professional area
• Keep oneself and peers abreast of current developments and trends in the professional area by reading and understanding internal procedures, attending training sessions, by writing/revising SOPs (as required), and by assisting Group Leader/Principal Specialists in training new employees
• Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process
• May serve as technical advisor for analysts with regard to QA/QC of data
• Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns

Qualifications

Basic Minimum Qualifications:

• Bachelor's degree in Chemistry or related science field
• Minimum of three years of pharmaceutical laboratory experience with knowledge of regulatory requirements
• Authorization to work in the United States indefinitely without restriction or sponsorship

Preferred Qualifications:

• Experience in performing Pharmaceutical analytical testing
• Computer skills including word processing, spreadsheets, PowerPoint and database is a plus
• Experience with cGMP and/or FDA regulated environments is a plus
• Technical writing and review
• Tracking action items and driving to completion
• Ability to identify trends in recurring events
• Batch record review, pharmaceutical testing and room clearance activities
• Work with the laboratory and support groups to improve quality metrics, and enable CAPA implementation
• Internal audits support
• Review/write QAU procedures.

Additional Information

Position is full-time, Monday-Friday, 8:00 a.m.-5:00 p.m. with additional hours, as needed.

We offer excellent full-time benefits including:

• Comprehensive medical coverage,
• Life and disability insurance,
• 401(k) with company match,
• Paid holidays and vacation,
• Dental and vision options.

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.