Quality Assurance Document & Training Manager - BioScience

Company: Smithfield Foods
Location: Cincinnati
Posted on: September 17, 2023

Job Description:

Your OpportunityThis is a full-time position reporting to the Director Quality Assurance. As a Quality Assurance Document and Training Manager at Smithfield BioScience (SBC), your primary responsibility will be to develop and maintain an effective quality management system (QMS) for SBC Document Management and Control as well as oversee the SBC Training system to ensure compliance with pharmaceutical regulatory requirements and industry standards. You will also oversee the QA review of cGMP documentation generated during routine activities at the facility. Salary Range $78,500 - $116,600 Core Responsibilities
Create, revise, and maintain company standard operating procedures (SOPs) and other cGMP documents throughout the document lifecycle, including initiation, revision, distribution, approval, and archival.
Coordinate archiving of cGMP records and obsoletion of expired records and documents.
Ensure controlled copies of SOPs are managed, updated and available at designated points of use.
Maintain inventory of approved and effective Master Batch Records and issue batch production records from approved Master Records.
Maintain validation files (e.g., validation protocols, summary reports).
Establish consistent and effective training curricula for SBC personnel in consultation with department managers, ensuring training is documented in accordance with regulatory requirements.
Develop training metrics to monitor compliance and effectiveness of the SBC training system.
Serve as system owner for SBC's electronic systems for Document Control (Trackwise DMS) and Training (Trackwise TMS).
Develop, implement, and maintain robust DMS and TMS quality systems aligned with relevant regulations and standards for active pharmaceutical ingredient (API) manufacture (e.g., 21 CFR Parts 210 and 211, ICH Q7, FDA Guidance documents).
Support customer audits and regulatory inspections with respect to training records and/or document requests.
Oversee New Employee Orientation, including evaluation of the program for effectiveness.
Coordinate the QA review of cGMP documentation generated at SBC, including raw material receipt; product manufacture, release, and dispatch; and other regulated activities associated with the facility.
Stay informed of regulatory changes, industry best practices, and technological advancements in the field, and update the DMS and TMS procedures accordingly.
Lead a team of QA Associates for these responsibilities at SBC.
Provide leadership for cross-functional teams, including training, coaching, and mentoring.
Counsel employees to promote their success and manage employee performance issues as needed
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. May perform other duties as assigned. QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions .
Bachelor's degree from an accredited four-year college or university in a science or technical field and 5 years of relevant experience performing Quality Documentation/Training duties in a cGMP environment (pharmaceutical industry preferred); or an equivalent combination of education and experience, required.
2 years of demonstrated experience in team management/development or project leadership is required, preferably in a pharmaceutical cGMP environment.
In-depth knowledge of relevant FDA regulations (e.g. 21 CFR Parts 210 and 211, 21 CFR Part 11, and ICH Q7)
Understanding of medical device regulations (e.g. ISO 13485, ISO 22442, 21 CFR Part 820) preferred.
Strong understanding of Good Manufacturing Practice (GMP) and its application in the pharmaceutical industry.
Experience in developing, implementing, and maintaining quality management systems, preferably in compliance with FDA requirements.
Familiarity and proficiency with the TrackWise DMS and TMS modules for Document Management and Training is a plus.
Experience with Good Documentation Practice and ALCOA principles.
Experience in developing and delivering training.
Strong technical writing skills and verbal communication skills, with the ability to effectively interact with cross-functional teams, regulatory authorities, and external stakeholders.
Strong computer skills including Microsoft Office and eQMS systems
Career BenefitsTo learn more about Smithfield's benefits, visit smithfieldfoods.com/careerbenefits.Why Work at Smithfield Foods? We are committed to meeting our employees' needs, addressing their concerns and helping them enjoy rewarding careers with our company. PEOPLE MATTERWith more than 60,000 jobs globally, our employees drive our success. We strive to create a fair, ethical and rewarding work environment.GROWTH & DEVELOPMENTWorking at Smithfield isn't just a job - it's the foundation for a lifelong career with training designed to help you advance professionally.BENEFITSOur people matter. That's why we offer excellent, comprehensive benefits packages to our full-time employees.SUSTAINABILITY PLEDGESustainability is ingrained in our culture and guides how we operate. We believe in innovating for the future.About Smithfield Foods Headquartered in Smithfield, Va. since 1936, Smithfield Foods, Inc. is an American food company with agricultural roots and a global reach. With more than 60,000 jobs globally, we are dedicated to producing "Good food. Responsibly--" and serve as one of the world's leading vertically integrated protein companies. We have pioneered sustainability standards for more than two decades, including our industry-leading commitments to become carbon negative in U.S. company-owned operations and reduce GHG emissions 30 percent across our entire U.S. value chain by 2030. We believe in the power of protein to end food insecurity and have donated hundreds of millions of food servings to our communities. Smithfield boasts a portfolio of high-quality iconic brands, such as Smithfield -- , Eckrich -- and Nathan's Famous -- , among many others. For more information connect with us on Facebook, Twitter, LinkedIn and Instagram. EEO/AA Information Smithfield is an equal opportunity employer committed to workplace diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veterans status, status as a disabled individual or any other protected group status or non-job characteristic as directed by law.

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