Quality Control Supervisor

we are currently hiring now. I strongly believe your skills and qualifications are a great match. Please let me know your interest so that we can discuss this further.

Job Title: Quality control supervisor

Location: Gainesville, GA, United States

US citizens OR Green Card

You will be:

• Provide Quality oversight at the - Georgia facility, inclusive of site Quality Control (including laboratory) and site Quality Assurance responsibilities.
• Provide effective supervision of Site Quality Department personnel. The Quality Supervisor must be willing and able to fulfill the responsibilities of most delegated tasks in the event of absences, heavy production schedules, etc.
• Ensure the Company's Georgia Site is in compliance with cGMPs and the Company's Quality Management System requirements, including compliance with Standard Operating Procedures, Master Batch Records, Specifications, Test Methods, GMP documentation/recordkeeping, Safety policies, etc.
• Ensure individuals involved in activities that directly affect the manufacture of products are in compliance with FDA regulations and company Quality policies through coaching, guidance, training, and working with Departmental Heads.
• Ensure Quality staff follows company safety policies and OSHA requirements.
• As a Site Management Team member, effectively communicate with company managers and staff members to coordinate activities, identify problems, and resolve problems in a productive and efficient manner.
• Ensure that appropriate processes, controls, and verifications are in place and being followed to produce products (and provide laboratory services) that meet customer and company requirements and specifications. When deviations occur, ensure thorough investigations are conducted to determine probable root cause and corrective action plans are implemented to prevent recurrence.
• Routinely conduct Site GMP self-audits, communicate results, and work with Site personnel to correct audit deficiencies.
• Analyze Quality operations and provide status reports to management - including but not limited to deviations, root cause/CAPA, audit results, quality metrics trends, and other data that help to define the overall status and effectiveness of the Site's quality compliance to Company's Quality Management System and cGMP regulations.
• Review and approve or reject reports/records/data submitted for Quality approval, including Production batch records, Laboratory Test Reports, Certificate of Analysis, Investigations and CAPA plans, product/ component disposition, Standard Operating Procedures, Validation/Qualification Protocols and Reports, etc.
• Ensure Quality documentation system is in place, current and effective at site level.
• Assure delegated responsibilities, tasks and activities are assigned to qualified personnel. Recruit, develop, coach and mentor employees with the goal of producing qualified, productive personnel capable of keeping abreast of changing technologies, customer needs and quality standards. Works with human resources and Site Manager (also Corporate Quality) on recruitment and selection of qualified Quality staff.
• Implement effective training programs that teach and mentor the organization as it relates to cGMP and Quality System compliance at the Site.
• Effectively coach and mentor Site Quality staff through periodic performance reviews, progress reports, and disciplinary action as needed or required.
• Work directly with the Corporate Quality Team and Site Manager on continuous improvement opportunities within the Quality department and/or facility.

• A bachelor's degree in a related science field is required. Five or more years of supervisory / management experience working in the quality field. Computer skills are required.
• Successful experience working with Sr. Management to implement plans and strategies that achieve results.
• Successful experience implementing systems, processes, procedures, specifications, and corrective actions that support and deliver results relative to strategic vision.
• Working knowledge of FDA GMP regulations - 21CFR 110 / 117, 21CFR 111, 21CFR 211, 21CFR 11, and HPUS.
• Working knowledge of botanical/herbal ingredients and products is a plus.
• Ability to review large amounts of data/information; identify trends, draw conclusions, and take action to achieve results.
• Excellent written and verbal communication skills, including technical writing skills. Able to communicate with customers and suppliers.
• Proven track record of being able to interact effectively and professionally with employees, customers, suppliers, senior management, and support departments and assist with FDA investigations.
• Successful experience in managing the selection, assessment, training, development, work direction, coaching, and quality of work life of direct reports and entire quality operations.
• Successful experience developing and delivering effective competency-based training programs.