Qa Manager

SUMMARY
In depth knowledge of and experience in 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. SQF Practitioner and PCQI certified. Assists production personnel with maintaining the plant and equipment in a sanitary condition.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

1. Manages and directs Quality Assurance staff. Trains, supports and oversees development of QA team to 21 CFR Part 11, SQF standards and HACCP. Responsible for interviewing, hiring, scheduling, counseling, discipline, and performance reviews for Quality Assurance staff.

2. In house 21 CFR111 Quality Unit Expert, SQF Practitioner and HACCP Coordinator. Responsible for creation, and upkeep of Dietary Supplement and SQF procedures, forms, records and documents.

3. Dietary Supplement: Review and approve all Master Manufacturing Records (MMR) and Batch Production Records (BPR) and all modifications to such records.

4. Preventative controls qualified individual – PCQI.

5. Authority to conduct material review and make disposition decision, and approving or rejecting any finished product (dietary supplements or food) that does not meet specification. Manage any reprocessing that may be required.

6. Oversees the disposition of customer returns.

7. Insures manufacturing, packaging, labeling and holding operations meets customer, certifying body, and regulatory requirement.

8. Approve testing procedures, including any related deviations, approving documentation for ensuring dietary supplements meet identity, strength, purity and composition.

9. Approving specifications for including but not limited to raw materials, components, dietary ingredients, finished products, labels, etc.

10. Approving Quality Control (QA) laboratory test results, including any related laboratory out of specification (OOS) investigation, and testing procedures.

11. Oversee Corrective Actions.

12. Provides support and guidance to the production department on all quality and allergen issues. Monitoring and ensuring the maintenance of quality standards. Maintain data on defects and report findings to the production department for their use.

13. Responsible for the overall operation of the analytical laboratory. Arranges for samples to be sent to an outside lab when needed.

14. Manages the routine inspection and testing procedures of raw materials, goods in process and finished product.

15. Maintains records on dietary supplement production records, quality, pest control, sanitation and allergens, SQF and HACCP.

16. Performs SQF system verification and validation and coordinates internal SQF audits. In the absence of the Quality Assurance Manager the Plant Manager will handle the daily SQF verifications and validations.

17. Accompanies inspector during FDA, Dietary Supplement, SQF audits.

18. Together with the production management, works to identify and correct product defects in order to minimize rejects.

19. Overseeing sampling and retain programs: Retains production samples by code date per procedures.

20. Act as quality and technical liaison on related issues for Jelly Belly Candy Company with its vendors and/or customers.

21. SQF document organization, filing.

22. Reports all safety incidents.

23. Overseeing the facility Sanitation Standard Operating Procedures (SSOP’s) for record keeping, training and corrective actions.

24. Overseeing the facility Training Program per certification requirement for implementation and maintenance.

SUPERVISORY RESPONSIBILITIES
Directly manages the activities of Quality Assurance with QA employees.

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE
Bachelor’s degree (B.A.) from a four-year college or university; and three (3) to five (5) years working experience manufacturing SQF practitioner, HACCP, PCQI certification desirable

LANGUAGE SKILLS
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.

MATHEMATICAL SKILLS
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent.

COMPUTER SKILLS
Excel, PowerPoint, E-mail and Word.

REASONING ABILITY
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Employee must seek assistance on anything over 50 pounds. Specific vision abilities required by this job include close vision and the ability to adjust focus. Occasional air, ground, sea travel to various sites. Long, early, and late hour, daily time work requirements.

WORK ENVIRONMENT
The work environment characteristics 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 functions.

The noise level in the work environment is usually moderate.

**All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.**