Batch Release Auditor

The Batch Release Auditor is accountable for ensuring the conformance of the manufacturing and packaging processes to the current Good Manufacturing Practices (cGMPs), company policies and internal procedures. Performs in process GMP audits, documentation review and final release of finished product that meets established specifications., * Partners with the departments to solve potential compliance issues in a proactive way to deliver product on time

• Establish recommendations and decisions to prevent process and/or product deviations; Failure to effectively perform this role could result in product recall and/or product delays
• Audits all batch records prior to disposition and/or review necessary documents to support product; Release product to market that is compliant to internal, local, state and federal regulations
• Strive to improve process inefficiencies to maintain batch records to improve efficiencies
• Ongoing maintenance of record retrieval system in tandem with QA staff
• Demonstrates comprehensive, site-specific knowledge of all manufacturing processes (e.g., Soft Gel, Solid Dosage, Bulk Packaging, Powder, and Gummy)
• Reviews and verifies manufacturing records at all production stages for accuracy and completeness
• Complies with "Right the First Time" metrics established in the organization
• Review and interpret deviations to assess impact and determine appropriate disposition in alignment with quality standards
• Exercises judgment on the resolution of production problems to meet company standards for quality, cost, and critical factors; makes decisions and works with precision in a fast-paced environment
• Defines problems and collects data; establishes facts and draws valid conclusions
• Performs mathematical calculations: adds and subtracts, divides all units of measure using whole numbers, common fractions, and decimals; calculates discounts, profits, selling price, proportions, percentages, surfaces, volumes, weights, and measures
• Applies scientific and logical reasoning to evaluate complex manufacturing and quality challenges
• Creates charts and provides tracking for batch record issues
• Communicates cGMP observations and quality trends to management; delivers clear, data-driven insights to cross-functional teams

General Responsibilities

• Poses no direct threat to the health or safety of himself/herself, of others, or to property. Defined as a significant risk of substantial harm that cannot be eliminated or reduced to an acceptable level by reasonable accommodation.
• Requires regular attendance to perform essential elements as contained herein between the assigned start and end times for work.
• Performs such individual assignments as management may direct.
• Other duties as assigned.

Do you have experience in Manufacturing company experience?, Do you have a High school diploma or GED?, * High school diploma or equivalent

• 1 years' documentation, regulatory or office administration experience
• 2-3 years' experience in a cGMP regulated or similar manufacturing environment

Knowledge, Skills, and Abilities:

• Proficient with software programs including Microsoft Word, Microsoft Excel, and Microsoft Outlook
• Knowledge of electronic database (Trackwise) that manages Standard Operating Procedure (SOPs), Work Instructions (WI), deviations, CAPAs and material reviews
• Knowledge of inventory or resource planning system (Oracle, warehouse management system)
• Must be able to interpret specifications and operational records
• Highly organized individual with excellent written communication skills
• Ability to interact with various departments and skill levels in a professional and consistent manner.
• Excellent English and Math skills
• Self-motivated individual and able to work with limited supervision
• Knowledge and experience in cGMP / FDA regulations
• Auditing exposure in a food, nutraceutical, pharmaceutical or government regulated industry is desired
• While performing the duties of this job, the employee is regularly required to talk or hear and sit. The employee is occasionally required to reach with hands and arms. Specific vision abilities required by this job include close vision.
• Walking and standing for extended periods of time.
• Lift Totes / Bins / Boxes with manufacturing documents (~20 lbs).
• Ability to read, write, and communicate in English