QA Coordinator Production en undefined

Since 1980, NAI has been a leader in nutritional health, bringing whole food-based supplements to a global population. NAI is a leading expert and manufacturer of dietary supplements, and we are involved in every facet of the industry, including research, development, manufacturing, marketing, and advocacy. As a company, we continue to grow with manufacturing locations in Vista and Carlsbad, CA. We are looking for seasoned and entry level candidates that are interested in working for global company with opportunities for growth, development, competitive pay, and benefits.

Summary

The Quality Assurance Coordinator Production is primarily responsible for reviewing and reconciling manufacturing and packaging batch records, reviewing test records and authoring bulk releases to package and shipment of released packaged goods. Interacts with quality departments of external customers. Create product certificates of analysis. Interact with Operations departments to ensure cGMP compliance.

HOURS: 3:15 pm - 11:45 PM, Monday - Friday

Essential Duties & Responsibilities

• Performs review and reconciliation of bulk and packaging batch records, approves release to package of bulk product and shipment of released packaged goods.
• Reviews lab testing data as it pertains to release of bulk and packaged product. Create product certificates of analysis.
• Initiates failure investigation of non-conforming materials and product, proposes corrective action/final disposition and submits findings to QA Management for discussion.
• Guides and directs the Quality Assurance Inspectors in prioritizing daily activities and meeting departmental timelines.
• Interacts with operations departments with regards to documentation, product quality, and cGMP compliance.
• Trains Quality Assurance Inspectors in performing required job tasks.
• Understands and follows company procedures and policies for inspecting materials and finished product established in compliance with the 21 CFR 111, Dietary Supplement cGMP.
• Understands and follows written instructions provided in company procedures and specifications. Notifies QA Management of any deviations to procedures or specifications. Obtains instructions and approval for handling deviation prior to initiating action.
• Audits Manufacturing and Packaging operations and performs in-process and final inspections of bulk and finished products ensuring cGMP compliance and adherence to company procedures.
• Approve labeling (expiration dating, correct label revision, lot numbers, and coding placement) according to batch record specification prior to start of packaging batch .
• Performs physical inspection and testing as required such as Identity testing using FT-IR analyzer, pH, Loss  on Drying using moisture analyzer, loose and/or tapped density, sieve analysis using various screens with Ro­ tap equipment.
• Inspects finished bulk and packaged product, using statistical sampling plans, to verify conformance to specifications.
• Completes and files required documentation
• Able to communicate and interact effectively with Purchasing, Planning, R & D, Distribution, Inventory Control Operations, Client Management and Quality personnel.
• Oversees management of blend, bulk and finished good retains.
• Oversees cleanliness and safety of equipment of work areas.
• Writes and/or revises Standard Operating Procedures and batch specifications through established Document Change Control processes.
• Assist QA Management in determining staff priorities and objectives.
• Performs other jobs as requested.

 Qualifications

• Education/experience Minimum: High School diploma with minimum 3 years experience or BA/BS degree in biology, chemistry, engineering, quality or applicable science with 2 to 3 years experience in quality assurance or quality control (preferred).
• Proven organizational skills and task management ability .
• Proven self-starter possessing the ability to complete projects and work in a team environment.
• Proven ability to initiate and maintain quality data, documents, reports, and corrective action summaries.
• Proven ability to review batch records and other technical documents to ensure product meets all required specifications.
• Ability to assist in the coordination of staff projects to meet Quality Assurance timelines and objectives. Ability to communicate project(s) status in a timely and effective method.
• Strong computer skills and knowledge of Microsoft Word, Access, and Excel software. 

Physical Demands

• While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms; grasp; stoop and kneel; talk and hear. The employee is frequently required to sit and stand.
• Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus.
• Lifting requirement: Up to the maximum safety -recommended 50 pounds.
• The physical demands are representative of those that must be met by employee to successfully perform the essential functions of this job. Reasonable accommodations may be made upon request to enable individuals with qualified disabilities to perform the essential functions of the job.

Training

Standard Operating Procedure training required upon initial new hire training, annually,  and as SOP's are updated, annual HACCP and GMP training requirement with assessment. Management or supervisory training seminar s or classes. 

Decision Making

Employee will make decisions related to manufacturing product evaluations and conformance with batch record specifications. Employee will determine if product is suitable for release to next operations and release for shipment. Employee will be required to make Manufacturing judgment calls and/or escalate Manufacturing issues to Management. Employee will be required to investigate non-conformances and propose corrective actions/final dispositions. 

Communication

Strong communication skills both written and verbal. Requires interaction with multiple departments internally at NAI and externally with NAI's customers. 

Results of Action

Employee evaluation of product/documentation will determine whether product is acceptable for shipment. 

Equipment Used

FT-IR (ID testing), pH Meter, sampling tools, scales, hydraulic carts, pallet jack, particle size analyzer, PPSL tester, bulk density/tapped density tester, moisture analyzer, disintegration equipment, cylinders, weigh pans, petri dishes, personal computer and multiple printers. 

Work Environment

Working in office area, as well as in warehouse and production areas, near forklifts, packaging, and manufacturing equipment. Hair restraints, gloves, lab coats, etc. are worn occasionally throughout the work day.

Benefits

• Medical plan options – Two HMO and one PPO
• Dental, vision, life insurance and other voluntary benefit options. 
• 3 weeks’ vacation and 11 paid holidays
• 401K including company matching and profit sharing
• $1,000 Employee Referral Bonus
• Quarterly employee lunches, Employee of Month and other recognition programs
• Opportunities for advancement
• Comprehensive training
• Tuition Reimbursement and more!

NAI is an Affirmative Action/Equal Opportunity Employer and will consider all applications without regards to race, sex, age, color, religion, national origin, intersectionality, veteran status, physical or mental disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.  

Upon this conditional offer of employment, a satisfactory completion of a background check (including criminal records check) with submission and passing a pre-employment post offer drug test is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position. Upon successful completion of the background check process, we will determine the date when your employment begins. NAI utilizes E-Verify to electronically verify employment eligibility.