Staff Scientist, Data Review - QA
Location: Columbia, MO
Staff Scientist, Data Review-QA
Eurofins BioPharma Product Testing has delivered expert scientific support to companies working to improve human and animal health. As a member of the Eurofins BPT team, you'll work alongside respected technical experts dedicated to scientific excellence in a process driven regulatory compliant environment.
Eurofins BioPharma Product Testing - Columbia is hiring for a Staff Scientist for Data Review in our Quality Assurance department. We are looking for an individual for a quality assurance position which provides assistance in improving quality processes and ensuring compliance with cGMP and/or GLP systems and regulations. Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Duties involve cGMP and/or GLP compliant functions.
- 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.
- 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.
The Ideal Candidate would possess:
- Performs other related duties as required and directed.
- 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.
- Experience reviewing Empower.
- Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Working knowledge of basic laboratory statistics is preferred.
- Ability to define and solve practical problems, present solutions, establish facts, and draw valid conclusions.
- Ability to deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Must be able to read, write, comprehend, and speak English.
- Written documentation is legible and sufficiently fluent (in English) to be understood by others.
- Ability to read, analyze, and interpret professional journals, technical procedures, or government regulations.
- Ability to read and interpret document such as study protocols, standard operating procedures, safety policies, instrument operation and maintenance instructions, and procedure manuals.
- Ability to summarize data and results.
- Ability to write reports, correspondence, and procedure manuals.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and others
- Bachelor's degree and five (5) years of directly related experience is required. A science 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.
- In rare cases, comparable demonstrated competence and experience in the relevant area may be used to substitute in whole or in part for the Bachelor's degree.
- Previous chromatography review experience (Empower).
- QA or quality data review experience with GMP or GLP.
- Authorization to work in the United States indefinitely without restriction or sponsorship
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 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. 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.