Position Summary:
Ensures compliance with all US and International Quality requirements including participation in all agency audits. The QA Supervisor oversees inspections and test functions and provides timely feedback to management on product quality trends.
Responsible for the inspection of all raw materials, work-in-process (packaging and manufacturing) blends, liquids, purchased and manufactured finished products. Responsible for the Label Room and Return functions. Responsible for the compilation and review of all batch records, test data, inspection reports, vendor s certificates and calibration program.
Position Scope:
Supervises 10 direct reports (8 QA Inspectors [includes 2 Leads], Label Room Attendant and Quality Return Clerk @ Distribution Center). Full-time shift and evening shift.
Position Responsibility:
- Direct supervision of Quality Inspectors who perform raw material, in process and finished goods inspection.
- Direct supervision of Label Room Attendant who maintains accurate inventory of label, accuracy of content and control of distribution to production.
- Direct supervision of Quality Return Clerk who assesses returned goods and determines disposition; samples and releases third party finished goods; identifies expired or tainted products; and enforces organic certified regulations.
- Enforces the Standard Operating Procedures (SOP s) that are applicable to Production (Manufacturing and Packaging) and Distribution.
- Responsible for halting a process once it is found to be a deviation of the SOP. Issues deviations in accordance with the SOP s. Issues material status notices, deviation and investigation numbers to ensure control of all non-conforming material. Tracks the deviation to ensure proper completion of relevant documentation prior to release of product. Summarizes and trends the deviations consistent with cGMP requirements.
- Compiles and review all batch records, inspection reports, vendor s certificates which are forwarded to the release area from other departments and facilities.
- Ensures that appropriate documentation is present in the file as required, e.g. deviations, investigation/hold reports.
- Reviews and logs batch records issued and confirms assignment of correct lot number in the electronic system. Ensures that additional documentation, e.g. investigation reports, hold notices and deviations, is included. Responsible for the computer transaction release and generating release stickers.
- Supervises additional personnel who may assist with the compilation of required records and performance of other activities within the area.
- Maintains all history files and logs pertaining to products.
- Releases all raw materials, bulk goods and finished products in a timely manner to ensure service level.
- Communicates, orally and written, with other departments both internally and externally to provide status updates, e.g., Purchasing, Distribution.
- Communicates with the Purchasing department and outside vendors to obtain paperwork needed for product release.
- Provides technical assistance as necessary to ensure that products meet all required specifications.
- Attends inventory planning meetings to advise Production regarding status of materials and to obtain production requirements for ensuing time period.
- Evaluates activities within release area and makes recommendations to improve and streamline process.
- Reviews, edits, and drafts department SOPs to ensure continued compliance with applicable regulations.
- Trains additional personnel in tasks and duties in the release area and to ensure coverage as necessary.
- Must wears Personal Protective Equipment (PPE) at all times as stipulated by SOPs, e.g. respirator, ear plugs, hair net, beard cover and uniform.
- Human Resource functions to include managing Total Reward Program as appropriate for their department, subordinate performance reviews, recommending promotions, issuing disciplinary warnings, time clock administration, as well as work shift assignment scheduling.
- Maintains professional and technical knowledge by attending educational symposia; reviewing professional publications; establishing personal networks; participating in professional societies, etc.
- Satisfactory completion of appropriate corporate training as related to the position and/or department.
- Assures compliance by following Food and Drug Administration's Good Manufacturing Practices as well as other regulatory standards as required by the department.
- Contributes to overall achievement by accomplishing related tasks and demonstrating characteristics that exemplify team building and support.
- The above is not intended to be an all-inclusive list of responsibilities. Other activities may be assigned as required by management.
QUALIFICATIONS
Experience and Skills:
- 5 years prior experience in a Quality Department in the area of pharmaceuticals or Natural Products including prior Supervisory experience.
- Must have strong problem solving skills and be able to assist the team when quality issues arise.
- Demonstrated leadership abilities and good interpersonal skills
- Demonstrated ability to work well on cross-functional teams with project management skills.
- Proven strong written and oral skills, together with strong organizational and management skills are a must.
- Ability to be self-motivated as well as work in a team environment
- Ability to train employees, both inter- and intra-departmentally
- Good attention to detail
- Strong competence in office software applications including Excel, Word, Outlook (Power Point a plus) and mainframe experience.
Education and Certifications:
- High school degree, preferably science oriented, college level course work preferred
- American Society for Quality (ASQ) courses / certification a plus