Associate Scientist, Data Review
Eurofins BioPharma Product Testing Columbia, Inc.

Job Info

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Associate Scientist/Data Review-QA

Eurofins BPT-Columbia is looking for an Associate Scientist/Data Review in our Quality Assurance team located in Columbia, Missouri .

The Associate Scientist/Data Review position is an intermediate-level professional position involved in somewhat complex day-to-day activities in a laboratory setting under prescribed processes (protocols, standard operating procedures, methods, etc.). Responsibilities include completing work for research and development under CGMP and/or GLP guidelines for studies, documentation, etc. Assisting in conducting, monitoring and reporting studies to ensure data accuracy and report quality. Providing somewhat complex analytical work on projects and studies using a range of analytical techniques and instruments. Working with increasing independence on studies and assignments.

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.).

• 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:

• Experience with GLP and/or GMP and hands-on experience with HPLC and/or GC.

• Experience with LIMS system desirable.

• Experience reviewing Empower.

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

• A highly motivated staff member that is not afraid to make mistakes but must learn from them, be willing to work on a team, and be willing to work with others to teach and learn new skills.

• Good organizational skills; ability to follow direction and good communication skills are required.

• 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 relevant field such as chemistry, biochemistry, biology, chemical engineering, pharmaceutical sciences, or other directly related field or degree with comparable coursework in the above areas and a minimum of two years of experience in a directly relevant or demonstrated comparable competency and skill attainment is required.

• A Master's degree in a relevant field may be substituted for the bachelor's degree and experience.

• One year bio/pharmaceutical experience with knowledge of regulatory requirements 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.

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