QA Associate II
Eurofins BioPharma Product Testing Columbia, Inc.

Job Info

---

Quality Assurance Associate II

Eurofins BPT-Columbia is looking for a Quality Assurance Associate II to join our Quality Assurance team located in Columbia, Missouri .

This is an advanced quality assurance position responsible for performing a variety of activities to ensure compliance with CGMP and/or GLP regulations by conducting audits, training programs, data, documentation, and report reviews, and analyses. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. May determine methods and procedures on new assignments and may provide guidance to other department staff. Duties involve CGMP and/or GLP compliant functions.

Employee Responsibilities:

• Reviews and approves/rejects completed client laboratory reports and manufacturing records for accuracy (of entry provided, e.g. lot numbers, calculations, etc.), traceability, and completeness. Evaluates addressed deficiencies for clarity and for potential impact on compliance status. Works with staff to correct any noted deficiencies and/or inconsistencies.

• Assists with development, implementation, and monitoring of quality systems and procedures (e.g. CAPA, Change Control, Training, etc.).

• Responsible for assigned Quality System (e.g. Investigations, CAPA, Metrics, Change Control, etc.). Has signature authorization for assigned Quality System.

• May perform the essential job duties and responsibilities of manager or supervisor to cover for vacations and extended absences.

• Reviews and approves equipment calibrations, qualifications, and validations for adherence to company procedures and federal guidelines.

• Performs internal, external, and quality audits (CGMP, GLP, and DEA, etc.).

• Develops content and format of training materials for GCMP and/or GLP and QA. Executes training for new and existing employees. Organizes and presents training sessions to groups or individuals.

• Reviews protocols, procedures, data, reports, and other documents to ensure accordance with specified regulatory requirements, protocol, and/or project plan, methods and SOPs.

• Works with study directors, principal investigators, and study owners to detect and resolve any quality issues.

• Reviews standard operating procedures for accuracy and consistency to ensure agreement with regulations.

• Updates the Master Schedule in accordance with specified regulations and standard operating procedures.

• Files protocols, amendments, deviations, inspections, and other quality documents appropriately.

• Keeps supervisor informed of significant issues or developments identified during quality assurance activities.

• Performs other related duties as required and directed.

The Ideal Candidate would possess:

• Solid foundation and knowledge of Good Laboratory Practices (GLP) and/or Current Good Manufacturing Processes (CGMP).

• Thorough knowledge of applicable guidelines.
• Good organizational skills; ability to follow direction; good communications skills and ability to read and understand protocols, SOPs, and technical guidelines.
• Compliance with regulatory guidelines and company SOPs (CGMP, GLP) is required.

• A working familiarity with regulatory guidelines is preferred.

Minimum Qualifications:

• Bachelor's degree and two (2) years of directly related experience is required. A degree in a relevant field such as chemistry, biochemistry, biology, chemical engineering, pharmaceutical sciences, or other directly related field or degree with comparable coursework is preferred.

• Familiarity and/or experience in a laboratory setting is preferred.

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

What we offer:

Position is full-time, Monday-Friday, 8 a.m.-4:30 p.m., with overtime as needed. Candidates currently living within a commutable distance of Columbia, MO are encouraged to apply.

As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, and dental and vision options.

To learn more about Eurofins, please explore our website www.eurofinsus.com .

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

As a part of Eurofins BioPharma Product Testing - the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide - Eurofins BPT provides comprehensive laboratory services for the world's largest pharmaceutical, biopharmaceutical and medical device companies. Our service offering includes comprehensive chemistry, biochemistry, microbiology, molecular and cell biology and biosafety testing of drug substances, final products, intermediates, and starting materials for both small and large molecule drug products.

We are looking forward to receiving your application including your expected salary and possible start date via our career website.

---