Supervisor, Quality Assurance

Summary

The Quality Assurance Supervisor is responsible for the supervision of Quality Assurance staff and activities by prioritizing the pre-executed and post-executed batch records, incoming receipts, label inspection and approval, and Analytical documents.

This position will be responsible for coordination of project activities, timelines, and schedules. The Supervisor will work internally with different departments to understand client and project requirements and communicate to the Quality Assurance team for development of project specific tasks and timelines. Additional responsibilities include, but are not limited to, resolution of customer quality issues, review and approval of Annual Product Review, Quality Agreements, investigations, CAPAs, assist in equipment and facility qualification, regulatory support, and quality process improvement.

Essential Duties And Responsibilities

The following is a list of minimum responsibilities related to this position. Other duties may be assigned.

• Provide leadership, support, and oversight of manufacturing, packaging, labels, release of material, pre & post executed batch record review, review of investigations, distribution instructions, component specifications, and 3rd party labeling instructions.
• Review and update SOPs, policies and processes regularly to ensure all quality standards are in compliance with cGMP standards, FDA and all competent authority regulations and requirements.
• Establish training matrix for Quality Assurance employees and train the team to ensure current standards are communicated to all employees with respect to cGMP, SOPs, and safety issues.
• Support key internal stakeholders on the project requirements and timelines.
• Maintain metrics for batch record review right first time and error tracking.
• Provide input to the development of personal performance goals.
• Assist process improvement initiatives related to Quality Assurance.
• Lead efforts and assist in appropriate problem-solving initiatives to address customer quality issues.
• Review and approval of validation protocols and equipment qualification.
• Responsible for approval of customer Quality Technical Agreements.
• Review and approve Annual Product Reviews (APRs) to assure compliance with company policies, cGMPs and regulatory requirements.
• Manage the clinical label release and issuance processes ensuring proper quality and compliance standards are met.
• Review and approve documents, such as Change Controls, NCRs, Complaints, Investigations Reports, CAPAs to ensure proper quality and compliance standards are met.
• Responsible for the review, approval and logistics of pre-executed and post executed batch records through QA department.
• Responsible for review and approval of analytical CoA’s, reports, stability protocols, calibration notebooks and method transfers/development testing protocols.
• Prepare written reports with recommendations for corrective and preventative actions to problems and changes to procedures to ensure high quality is the company standard.
• Participate in internal audits per schedule and review the results of audits to ensure resolution of any noted deviations.
• Review technical, regulatory publications, articles, and abstracts to stay abreast of new quality/technical developments in industry.
  
  

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.

• Bachelor’s Degree in a science or technical field.
• 3 years in pharmaceutical or biotech manufacturing in a Quality or Compliance role.
• Demonstrated ability to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines.
• Excellent oral and written communication is required to communicate with the team, peers, management, and external contacts.
• Effective communication, organization, planning, initiative, follow-through, and responsiveness skills are a must.
• Must have ability to work in a cross-functional team environment.
• Leadership skill to mentor and develop team to achieve company goals.
• Strong working knowledge of personal computers and Microsoft Office Products, including Word, Project, and Excel.
  
  

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.

While performing the duties of this job, the employee is frequently required to stand, walk and sit and regularly required to talk or hear. Employee is occasionally required to walk use hands to finger, handle or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds.

Specific vision abilities required by this job include color vision.

Environmental Conditions

While performing the duties of the job, the employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and working near moving mechanical parts. The noise level in the work environment is usually quiet.