Quality Control Supervisor

APOTHECA INC.

Apotheca Inc. was founded in 1987 in Woodbine IA and offers custom manufacturing of natural healthcare products. Apotheca produces formulations on a contract basis for distribution and marketing companies that share their commitment to products that truly improve people’s lives. Apotheca is known for their expertise in homeopathic, nutritional supplement and botanical manufacturing that has earned Apotheca a reputation for producing quality products. Our customers know that Apotheca will consistently produce a unique quality product to meet their expectations and deliver it as promised. Recently Apotheca expanded its production capability to Southeast region state of Georgia at Gainesville where they continue producing quality all natural products under Food and Drug Administration (FDA) regulation. We are looking for an experienced Quality Control Supervisor to oversee our Quality Control Department.

ESSENTIAL DUTIES AND RESPONSIBILITIES are to:

• Provide quality oversight at the Apotheca, Inc. – Georgia facility, inclusive of site Quality Control (including laboratory) and site Quality Assurance responsibilities.
• Provide effective supervision of Site Quality Department personnel. The Quality Control Supervisor must be willing and able to fulfill the responsibilities of most delegated tasks in the event of absences, heavy production schedule, etc.
• Ensure Apotheca’s Georgia Site is in compliance with cGMPs and Apotheca’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 product 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 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) which 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 helps to define the overall status and effectiveness of the Site’s quality compliance to Apotheca’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 Corporate Quality Team and Site Manager on continuous improvement opportunities within the Quality department and/or facility.
• Articulate and communicate the company’s vision of Quality consistently throughout Apotheca’s Georgia Site.
• Promote Grato Holdings organizational core values.

MANAGEMENT RESPONSIBILITIES

The Quality Control Supervisor must display the qualities of being a respectful coach, mentor, change agent, team player, and leader to employees, peers, and management. This job directly manages the Quality Control and Quality Assurance site operations for Apotheca, Inc. (Georgia) and all staff members within these functions. The Quality Control Supervisor has the responsibility and authority to halt processes that are not meeting customer or company quality expectations. The Quality Control Supervisor has the responsibility to provide consult and guidance for correction and change. The Quality Control Supervisor is responsible for supporting other managers/personnel in the development of corrective actions and process changes as needed and approving or rejecting such changes.

QUALIFICATIONS

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 with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

Bachelors’ degree in a related science field required. Five to Seven years supervisory 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 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 will 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.

LANGUAGE SKILLS

Ability to read and interpret documents such as regulations, compliance standards, legal documents, procedure manuals, and financial statement. Ability to write procedures, protocols, reports, investigation and corrective action reports, and other general management level reports and correspondence. Ability to effectively present information and respond to questions from managers and other employees of the organization.

MATHEMATICAL SKILLS

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, percent and proportions. Able to operate a 10 key calculator.

REASONING ABILITY

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

CERTIFICATES, LICENSES, REGISTRATIONS

None

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to stand, walk, reach with hands and arms, talk, hear, and smell. The employee is occasionally required to sit, climb, and kneel. The employee must be able to regularly lift and/or move up to 75 pounds. Specific vision abilities required by this job include vision, distance vision, color vision, peripheral vision, and depth perception.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The main functions of this position are performed in an office environment but must be able to work and assist in the production areas. While performing the duties of this job the employee is periodically exposed to high heat from grills & kilns, airborne particles while grinding and odors from herbs and essential oils while in the production areas. The noise level in the work environment is usually medium in the production area.

SUMMARY

The Quality Control Supervisor will perform all duties as listed but will not be limited to these duties. Whenever assistance is needed in other areas of the company’s operations, the Quality Control Supervisor will help in any way they may be qualified. The company mandates that all employees conduct themselves in a professional manner conducive to a team approach environment. Actions or mannerisms that deviate from this approach will not be tolerated.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Employee discount
• Health insurance
• Health savings account
• Paid time off
• Retirement plan

Schedule:

• Monday to Friday

Work Location: In person