Thermo Fisher Scientific Inc.
Saint Louis, MO, United States
Sciences, Engineering, Compliance, Accounting
Leads a multidisciplinary team of laboratory, operations, compliance, validation, quality, and engineering personnel to ensure all CGxP data is collected, protected, archived, preserved, and retrievable according to industry and regulatory guidelines. Ensures the Research/Quality Operations have awareness of Data Integrity as it relates to paper and electronic records and ensures good documentation practices for electronic and paper based data are in place. Proficient in the application of 21CFR Part 11 and Annex 11 regulations as well as stays current with updates to these regulations.
Ensures all new equipment and instrumentation is assessed appropriately and validated for its intended use and existence, usage, and review of audit trails and 21CFR Part 11 and Annex 11 regulations.
Communicates actions, compliance gaps, and commitments to respective areas, including the Site Director of Quality.
Performs risk assessments to determine high risk equipment and audit trails and take appropriate action to bring into compliance. Assist in sourcing, assessing, and recommending instrumentation/equipment for purchase.
Provides periodic training to all operations to ensure awareness and compliance with data integrity for both paper and electronic records, including inspector interaction and good documentation practices.
Creates/updates procedures as necessary to ensure operations awareness and importance of regulatory requirements and expectations. Routinely evaluates regulatory inspection documents and updates site procedures accordingly. Keeps the site aware of industry trends.
Creates and executes Change Controls for instrumentation/equipment. Aids in establishing user requirements for equipment.
Establishes and leads a Surveillance program to audit all GMP facilities within the site for compliance to establish documentation and data integrity standards, practices, and procedures.
Selects and evaluates staff to ensure the efficient operation of the function. Works with and advises staff on administrative policies and procedures. Serves as an advisor to Research/Quality Operations for Data Integrity matters. Represents the company as a subject matter expert during regulatory and customer audits for Data Integrity. Meets with vendors to discuss software capabilities in regards to 21CFR Part 11 compliance.
The position will coordinate and facilitate meetings with cross-functional groups to discuss data integrity. This position will be responsible for ensuring the site operates under applicable regulatory policies for documentation and data integrity/guidelines as well as striving for continuous improvement. The Data Integrity Compliance Officer is the point person during regulatory audits for Data integrity and plays a major role in regulatory and customer audits to answer questions and demonstrate to auditors that necessary controls and required competencies are in place for Patheon to maintain its license to operate.
Bachelor’s Degree in Science, Engineering, or related fields.
Strongly recommended to have at least 7 years experience in a regulated industry, or 5 years with related technical knowledge including data integrity related to quality control data from chromatographic systems, knowledge of laboratory instrumentation and/or operations equipment and associated computer systems and TrackWise.
Solid knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP). Experience in data review, 21CFR Part 11 instrumentation compliance as well as writing and reviewing investigations within TrackWise. Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Effective written, interpersonal, and presentation skills. Ability to work on multiple projects simultaneously.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific Inc.
Website : http://www.thermofisher.com
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands - Thermo Scientific, Life Technologies, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.