Job: Quality Assurance & Quality Control Manager

The position and primary function of the Quality Assurance and Quality Control Manager is to manage supervision, coordination and monitoring of all required Quality Assurance as well as Quality Control duties and responsibilities (which includes raw materials, packaging components, bulk and packaged finished products) to ensure compliance with all company policies, customer specifications and regulatory requirements.

This position requires but is not limited to the following duties:

1. Responsible for supervising, training, scheduling and monitoring the duties and activities of QA & QC personnel. Initiate communication with Director of Product Quality, Director of R&D & Technical Services, Vice President of Operations or Vice President of Sales as required and when necessary.

2. Ensure daily compliance with all customer requirements, procedures and product specifications which includes managing the product stability program.

3. Monitor product handling practices, Good Manufacturing Practices, Standard Operating Procedures, employee hygiene and plant operating conditions. Communicate directly with employees and supervisory personnel when deviations are identified and supervise corrective action. Use corrective action necessary to guarantee the production of safe high quality products.

4. Develop open lines of communication with inspectors and operations supervisors acting as liaison between the plant and management. Conduct weekly meeting with QA & QC personnel.

5. Review noncompliance records, meet/coordinate with all involved parties (department supervisor, production employees and technicians) to identify cause of deviation and possible corrective action. Draft appropriate reports (such as product complaint reports) and submit to Director of Product Quality.

6. Communicate and work with department supervisors to resolve issues in areas of concern and review and modify procedures as required.

7. Trouble shoots Quality Assurance issues throughout the plant, making recommendations for corrective action, when necessary.

8. Performs various duties / tasks as determined necessary by management to provide customer support

Must have (at a minimum) bachelors degree in chemistry, or related discipline.

Must have a good understanding of 21 CFR (Code of Federal Regulations) particularly Parts 110, 210 and 211. Must be familiar with USP/ NF reference compendia including USP’s section on GMP on Dietary Supplement.

Must have supervisory experience in a Quality Assurance and Quality Control in a Dietary Supplement and/or OTC processing facility.

Supervisory skills must include experience with multi cultural work environment.

Must be detail oriented and have excellent organizational skills. Must have excellent communication and inter-personal skills.

Must have strong computer knowledge, with experience in word processing,
spreadsheets and e-mail.

Must understand the importance of confidentiality. This includes any confidential information knowledge or data related to product, strategy or business affairs.

Must have the ability to independently plan and manage daily workload to meet production goals required.

Must have the ability to work in an environment that requires constant change and adaptation to workload priorities.

Must be able to establish and maintain cooperative working relationships with staff through both verbal and written modes.

Must have the ability to work effectively with peers and subordinates