QUALITY ASSURANCE ASSOCIATE

The following reflects management's definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.

• Review Master Manufacturing Records (MMRs) and convert to fillable PDFs for production checks.
• Issues new batch records for Production orders and pilot runs based on the Production schedule or assigned priorities.
• Update MMR and Batch Record status on the production schedule notes in a timely manner.
• Review completed batch records for compliance, reconcile any errors or missing entries, approve check sheets and release within 1 week of production finishing.
• Record, track, and report batch record status monthly including amount of BR issued, reviewed, scanned, filed and amount of MMRs converted.
• Record, trend, and report batch record discrepancy data monthly.
• Generate COAs for finished products and release finished products in ERP system and communicate it to all stakeholders.
• Assist in annual internal auditing of quality systems and closing the gaps.

• Keep all documentation (such as MMRs, batch records, raw material and finished product specifications, SOPs, complaint response forms, deviations,

• training quizzes, sign off forms etc.) organized, scanned and easy to find, both electronic and physical, to make sure the plant is always audit ready.

• Assist the QA manager during complaint investigations, root cause analysis, building and implementation of corrective/preventive actions.
• Maintain the training matrix to effectively track timely completion of training of each employee. Follow-up and send reminders if the due date is near or has passed.
• Maintain several logs such as deviation, change control, customer complaint log, rework, reprocess, in-process etc. ensure they are up to date. Follow up on deadlines to close them in time.
• Create and issue rework, reprocess, in-process forms as needed for production.
• Create, revise and maintain finished product specifications and get QA manager and customer approvals where required.
• Assist the QA manager during annual certification audits, regulatory audits and customer audits.
• Provide feedback and suggestions to Quality Assurance Manager on matters concerning quality operations and any continuous improvement projects.
• Assists with customer documentation requests; pulls, reviews, and sends documents required.
• Attend quality related and cross functional meetings; ensure no communication gaps, take notes on priorities for release.
• Performs other duties as assigned by the Manager.

• Bachelors in Science, Food Science, Chemistry or equivalent preferred
• 1-3 years of experience in quality assurance, Dietary Supplements preferred.
• Knowledge of GMPs, HACCP, allergens, food safety, quality control, document control required.
• Commitment to maintain food safety and quality standards
• Good communication skills
• Strong organizational, problem solving, and analytical skills
• Ability to manage priorities and meet deadlines
• Acute attention to detail
• Adapts and delivers results in challenging situations or during tighter deadlines
• Proficiency in Microsoft Word, Excel, Outlook, Adobe
• Ability to learn/work with software such as ERP system, project management tools, DocuSign and others
• Be available as a backup to other QA personnel when needed
• Available to work overtime if needed
• Bilingual skill (English and Spanish) is a plus.