Quality Records Associate 2nd Shift

Quality Records Associate 2nd Shift Location Mooresville, NC :

We believe being healthy should not require tradeoffs. SCN BestCo is a leading innovator, developer and manufacturer of Vitamin, Mineral & Supplement (VMS), Over-the-Counter (OTC) and prebiotics/probiotics in enjoyable forms such as gummies, lozenges and chews. With over 50 years of excellence, our team leads the way in changing how consumers make healthier choices. With unique food science expertise and proprietary processes, we've pioneered many firsts. Our passion to create new to the world products has guided and continues to be core to our mission of making health and wellness more enjoyable. Come join us and become a part of our winning formula!

• 2nd Shift

Essential Duties & Responsibilities:

• Audit manufacturing floor and logbooks to ensure compliance (at least monthly).
• Support Right First Time Initiatives (operational excellence program).
• Support batch review and release time.
• Facilitate the release of products and ensure proper control of materials in a cGMP environment.
• Issue Batch records and labels into production.
• Review batch records and release finished goods for OTC and Dietary Supplements.
• Ensure accuracy, integrity and completion of quality documentation.
• Generate and disposition product certificates/release documentation (Certificates of Compliance/Analysis) as required.
• Ensure documentation is provided to customers in a timely manner. Communicate with customers, as needed.
• Investigate and review quality events, including initiating holds when a quality event occurs and Initiating investigation reports and corrective actions as needed.
• Assist regulatory bodies/customers during the commercialization process through distribution of goods.
• Maintain executed batch records (BR) and related documentation.
• Directly support validation activities as needed.
• Directly support regulatory inspections, compliance audits, and other quality functions.
• Collect samples as required for validation activities, raw materials, and products.
• Utilize electronic documentation systems to review and release finished goods product, issue batch records, and execute other data entry tasks as needed.

Required Qualifications:

Education & Experience:

• High school diploma or equivalent.
• 1 year of professional quality assurance experience.

Knowledge, Skills, & Abilities (KSAs):

• Proficiency in Microsoft Office.
• Ambitious, critical thinking, self-starter with the ability to work under pressure in a fast-paced environment.
• Ability to work within a team on multiple projects simultaneously.
• Hygiene/safety orientated, with the highest level of personal integrity.
• 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 and to draw and interpret bar graphs.
• Must have the ability to communicate effectively, both verbally and in writing, with internal staff and management. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
• Must be able to demonstrate practical problem solving and trouble shooting skills. 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.

Preferred Qualifications:

• Associate degree in a related field.
• Pharmaceutical quality assurance experience.
• Experience with electronic documentation systems.
• Knowledge of Hazard Analysis Critical Control Point (HACCP).

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.