Quality Supervisor

Reese Pharmaceutical; Cleveland (OH); On-site; USD 80,000 - 110,000; Full time

Job summary

Reese Pharmaceutical is seeking a Quality Assurance Supervisor to lead the QA/QC team and oversee cGMP programs in a pharmaceutical manufacturing setting. You will drive continuous improvement, ensure regulatory compliance, and partner with operations to maintain product quality.

The role requires a Bachelor's degree in a related field and 5+ years of QA/QC experience, strong communication skills, and the ability to travel as needed.

Qualifications

• Bachelor's degree in science, mathematics, engineering or related field.
• 5+ years 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 (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.

Responsibilities

• 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.

Skills

Leadership

Regulatory knowledge

Communication skills

Microsoft Office

Computer skills

Travel flexibility

Education

Bachelor's degree in science, Mathematics, Engineering or other related field

Job description

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.

RESPONSIBILITIES FOR QUALITY ASSURANCE SUPERVISOR:

• 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/QUALIFICATIONS:

• 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 screens or other electronic devices.
• Use of various office hand and electrical tools or equipment.

SCHEDULE DEMANDS:

General schedule is a 8-hour Monday - Friday 7:30 am to 4:00 pm assignment, however, employee must be willing to work a flexible schedule including early mornings, and weekends and be punctual while doing so.