The Quality Assurance Supervisor operates under the general direction of the Director of Compliance and Quality Assurance and is responsible for overseeing daily functions within the Quality Assurance department. This role ensures compliance with current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs), and regulatory guidelines. The Supervisor uses discretion to make independent decisions and applies knowledge of industry best practices, cGMPs, SOPs, and regulatory requirements. Additionally, this role involves preparing management reports as requested.
Essential Responsibilities:
Ensure all staff comply with the company's SOPs, cGMPs, and regulatory guidelines.
Inspect production lines and ensure adherence to cGMPs, SOPs, and specifications.
Make decisions based on cGMPs and SOPs.
Organize and coordinate workload with staff.
Oversee incoming component inspection and release.
Manage finished goods inspection and release.
Schedule QA Inspectors to meet shift requirements.
Review and finalize batch records.
Review, write, or update SOPs as needed.
Release batches for shipment.
Manage CAPA, OOS, Customer Complaints, Change Authorization, and Deviations.
Process Questionable Material Reports (QMR), Material Destruction Records (MDR), and Rework Orders (RO) as needed.
Assign tasks and projects to team members and manage workflow.
Maintain appropriate QA records and documentation.
Identify and recommend solutions for process improvement and policy clarification.
Prepare and distribute management reports and other documentation related to areas of responsibility.
Participate in internal committees and complete special projects as assigned.
Demonstrate excellent interpersonal skills and professionalism in interactions with management, staff, vendors, and external agencies.
Adhere to company policies and procedures, setting a positive example for others.
Establish priorities to ensure timely job completion.
Supervisory Responsibilities:
This position has direct supervisory responsibilities for selected groups/functions within the Quality Assurance Department. Responsibilities include training, coaching, and developing employees, addressing performance deficiencies, conducting formal and informal performance evaluations, and recommending personnel actions such as position upgrades, salary adjustments, promotions, and terminations. The Supervisor also manages work schedules and assignments and addresses interpersonal conflicts within the department.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description. The requirements listed below represent the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Discretion: Handling confidential and sensitive matters with professionalism.
Knowledge: Understanding of Drug/OTC cGMPs, SOPs, regulatory guidelines, including FDA requirements, and QA industry best practices.
Education, Experience, and Licensure:
Bachelor's degree in science or a related field.
Minimum of 3 years of related supervisory experience in a manufacturing environment.
Technical Skills:
Proficient in Microsoft Office products, including Word, Excel, Outlook, and PowerPoint.
Ability to quickly learn new software programs as needed.
Language Skills:
Must be able to clearly and concisely communicate verbally and in writing in English. Must be capable of presenting information clearly and effectively in front of groups.
Mathematical Skills:
Ability to analyze and present quantitative data and accurately compute basic mathematical equations such as addition, subtraction, division, multiplication, and percentages.
Reasoning Ability:
The Quality Assurance Supervisor must be able to analyze and interpret data relating to various projects and resolve issues that arise, including:
Resolving routine and complex issues and escalating them to senior management when appropriate.
Effectively prioritizing work assignments to ensure goals and timelines are met.
Applying knowledge of Quality Assurance best practices, cGMPs, regulations, and company policies to provide appropriate resolutions.
Physical Demands and Work Environment:
The physical demands and work environment 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 job functions.
Must have good visual/organoleptic alertness.
Work is conducted in a standard office and manufacturing environment with associated distractions such as noise from telephones, keyboards, talking, paging systems, production equipment, and warehouse activities. Temperatures are regulated by facilities management.
The position requires movement within the company's premises, including offices, cubicles, warehouse, and production areas. The incumbent may need to drive to a second location a short distance away.
Must be able to sit for up to eight hours per day, lift and carry up to 20 lbs with or without assistance, reach above shoulder height, bend, stoop, and crawl to retrieve items. Regular computer use and standing while filing or performing other responsibilities are also required.
Exposure to standard chemicals used in an office environment is expected, as well as chemicals used in the manufacturing process of nutritional supplements, cosmetics, and prescription drugs.
Must have reliable transportation and a valid driver's license, and maintain current, in-force vehicle insurance.