Director, Quality Control - BioScience

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This position is one of leading all QC operations and enforcing strict adherence to USFDA's current Good Manufacturing Practices (cGMP) (e.g. 21 CFR Part 210/211 and ICH Q7), while ensuring the quality and integrity of the Company's products and quality standards. The Director QC will ensure the quality and integrity of laboratory operations is maintained during testing of the Company's active pharmaceutical ingredients (APIs) and medical device components.

• Leads the QC group to ensure testing is accurately performed and reported in a timely manner.
• Communicates directly with quality and production teams to collaborate in efficient and expedient manufacturing process flow.
• Oversees day-to-day management of cGMP compliance in all aspects of QC laboratory operations.
• Directs all equipment use and maintenance while ensuring best practices and optimized workflow.
• Guarantees all incoming raw materials, in-process samples, and finished products are tested for compliance with the Company's Standard Operating Procedures.
• Maintains the laboratory in a constant state of readiness for inspections by FDA and other national competent authority inspections.
• Knowledge of relevant analytical technologies for the analysis of pharmaceutical products (HPLC, FTIR, ICP, AA, UV/VIS Spectrophotometers, etc.)
• Periodically reviews laboratory Standard Operating Procedures and works with QA to update as required.
• Leads the writing of validation protocols and reports, the execution of studies, the development of new QC laboratory methods, and computer system validations.
• Guarantee laboratory OOS, CAPA, Complaint, and Deviation investigations are performed in accordance with FDA standards and guidance documents.
• Ensures proper staffing is maintained in the QC group to perform all required testing and the associated review activities.
• Informs management of any software or equipment necessary to maintain the laboratory in a state-of-art status.
• Participates in cGMP training of the Company's employees and in the training of laboratory personnel.
• Provides leadership and decision making in managing situations and issues relative to quality control.
• Regularly tracks data and trends key performance metrics for the laboratory and reports to senior site leadership

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.

To 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 in analytical chemistry or related field and 10 years of industry experience in quality control manufacturing systems; or equivalent combination of education and experience, required.
• Master's degree preferred
• 7+ years of experience in team development / management, required.
• Strong leadership skills and the ability to uphold regulatory, company, and customer standards.
• Strong decision making and problem-solving skills.
• In-depth knowledge of analytical techniques and instruments, including HPLC, UV/Vis, GC, ICP, Ion Chromatography, FTIR, AA, ICP-MS, and PCR, including troubleshooting and maintenance.
• Knowledge of compendial laboratory testing (e.g. USP, EP, and JP).
• Proficiency in quality system manufacturing processes, quality assurance principles, pharmaceutical manufacturing, SPC, statistics, and electronic QMSs (e.g. TrackWise).
• Excellent writing, interpersonal and communication skills (written and verbal).
• Excellent planning and organizational skills with demonstrated multi-tasking and project management experience.
• Ability to manage multiple priorities in a fast-paced environment.
• Capable of reading, following, and applying technical documents to QC operations
• Detailed understanding of cGMP (ICH Q7, CFR Parts 210/211, CFR Part 11)

• Provides leadership and guidance to the Quality Control team
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

IndSPR-Ops

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.

If you are an individual with a disability and would like to request a reasonable accommodation for any part of the employment selection process, please call us at 757-357-1595.