Quality Supervisor

Reese Consumer Health; Cleveland (OH); On-site; USD 70,000 - 90,000; Full time

Job summary

Reese Consumer Health in Cleveland, Ohio, is seeking a Quality Assurance Supervisor to lead quality management systems and ensure compliance with regulatory standards.

The ideal candidate will have at least five years of cGMP experience in pharmaceutical manufacturing and a relevant Bachelor’s degree. This role involves training the quality team, auditing processes, and employing continuous improvement strategies.

Qualifications

• Five or more years of experience in Quality Assurance/Quality Control, with a minimum of five years cGMP experience.
• Familiarity with 21 CFR part 210/211, part 111, and part 820.
• Excellent written and verbal communication skills.

Responsibilities

• Lead the quality team to meet quality objectives.
• Conduct audits and ensure compliance with policies.
• Perform root cause analysis and corrective actions.

Skills

Leadership

Regulatory compliance knowledge

Communication skills

Microsoft Office Suite

Problem-solving

Education

Bachelor’s degree in Science, Mathematics, Engineering or related field

Job description

Position Summary:

Incorporating our company values: Accountability, Continuous Improvement, Customer Focus, Integrity, and Quality. As a member of quality management, maintain and improve the company Quality Management Systems. The Quality Assurance Supervisor is responsible to lead quality control efforts and infrastructure in both Quality and Production.

JOB FUNCTIONS

• Train, motivate, and evaluate the quality team to meet the company’s quality objectives.
• Support the hiring and onboarding process in collaboration with department director.
• Collaborate with HR to build quality training program for continuous improvement and new hires.
• Audit and review the manufacturing process for compliance to policies and procedures and assist in investigating non-conformities.
• Participates in the data collection, development, and issuance of management review documents.
• Perform root cause analysis and other risk assessment activities to identify effective corrective and preventative actions to support continuous improvement of the quality system.
• Plans work, makes assignments, and coordinates workflow to balance safety, quality, and moral standards to meet company objectives and customer expectations.
• Performs root cause analysis and CAPA follow up (if required) for complaints and inquiries received from the field.
• Evaluate training needs for quality personnel employee’s, perform on-the-job training / re-training, and evaluate the effectiveness of the training.
• Review and approve change controls applicable to manufacturing processes and procedures, analytical procedures, and related batch records/testing Standard Operating Procedures (SOPs); assures appropriate reports are issued, approved, and implemented.
• Manages cGMP new employee and annual training for all employees at each facility.
• Oversee cGMP aspects of production records and develop quality and production SOP’s using the change control process, as identified through observation or the internal audit process.
• Communicate quality issues, trends and losses to operations management and identify appropriate resolutions with operations management assistance.
• Perform Annual Product Reviews (APR).
• Maintain a rotating schedule for NBE or own merit testing with a minimum of one product per month on new items and legacy products.
• Maintains oversight of the maintenance/calibration program.
• Perform periodic review of SOP’s and internal audits according to applicable procedures.
• Assist with internal and external quality audits including development of responses to observations.
• Apply systematic critical thinking to solve company issues.
• Other tasks as needed to support department and company goals and initiatives.

EDUCATION / KNOWLEDGE / SKILLS

• Bachelor’s degree in science, Mathematics, Engineering or other related field required.
• Five or more years of experience in Quality Assurance / Quality Control, with a minimum of five years cGMP experience in a pharmaceutical manufacturing environment.
• Familiarity with 21 CFR part 210/211, part 111, and part 820 desired.
• Ability to lead and direct others.
• Microsoft office suite experience.
• Experience with regulatory authorities (i.e. FDA, FTC, EPA) and inspection preparation, execution, and response preferred.
• Knowledge of inspection and control methods, techniques and documentation.
• Excellent written and verbal communication skills.
• Strong computer skills, including ability to manage quality control applications
• Ability to travel as needed.

PHYSICAL DEMANDS

• Frequently sitting or standing for extended periods of time up to 10-hours.
• Occasional bending, squatting, climbing, kneeling, and twisting required.
• Simple and power grasping with both right and left hands is required.
• Occasional Lifting up to 50 lbs.
• Reading computer screen or other electronic devices.
• Use of various office hand and electrical tools or equipment.

SCHEDULE DEMANDS

General schedule is a 8-hours Monday – Friday 7:30 a.m. – 4:00 p.m. assignment, however, employee must be willing to work a flexible schedule including overtime and days that may include early mornings, and/or weekends and be punctual while doing so.

Reese Consumer Health is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, age, gender or sex (including pregnancy), national origin, ancestry, marital status, sexual orientation, gender identity, genetic identity, genetic information, disability, veteran/military status or any other basis prohibited by local, state, or federal law. Click here to view the Poster, EEO is the Law.