Quality Associate III

The Quality Assurance (QA) Associate III position is responsible for performing advanced quality related functions within the organization’s quality program and reports directly to the Quality Assurance Supervisor/Manager. This position is responsible for ensuring that all products released by Goodier conform to all regulatory and quality specifications. This position may lead and/or train QC Inspectors and lower level Quality Associates. This position is multifunctional including the broad ability to execute all duties reference below but may routinely primarily focus on specific duties.

Essential duties and responsibilities

• Execute timely GMP review for Production Records, ensuring complete documentation compliance with cGMPs and Good Documentation Practices. Work with Quality and Production teams as needed to drive updates and accurate completion.

• Create and issue Finished Good Lot codes to Production. Serve as the primary trainer for new Quality Assurance Inspectors.

• Provide assistance with quality evaluations and release of materials, products, equipment and facilities where required.

• Perform, audit, verify, document and report AQL (Acceptable Quality Limits) inspections and testing to ensure compliance with requirements for Finished Goods and/or Components.

• Perform release of components and/or product for filling or distribution (systematically and/or physically as required per Goodier QMS processes). Prepare product Certificate of Analysis (COA) documentation as required.

• Elevate observed quality issues to Operations and/or Quality leadership to drive quick resolution, drive equipment adjustments, and coordinate additional actions / inspections as needed. May make independent quality issue decisions as required.

• Prepare and issue Quality Alerts as required for observed non-conformances.

• Support management of Finished Good rework lots and product or components that are on hold.

• Collect, organize, and prepare samples for third party test labs (3PL) testing.

• Review Microbiological test reports for accuracy and compliance to specifications.

• Input and maintain all microbiological test data in quality databases and/or electronic systems. Execute data trending as requested.

• Perform Environmental Audit testing.

• Prepare, organize, document, archive and manage the life cycle of Finished Product retain samples.

• Interface with all departments and other cross-functional colleagues to ensure systems and processes are in accordance with cGMP and Goodier standards and to ensure timely product and material disposition.

• Observe and monitor activity in production areas to assure adherence to procedures, Good Manufacturing Practices (cGMPs), and Good Documentation Practices.

• Perform other duties as assigned.

Qualification requirements

• High school diploma or equivalent.

• Quality experience (5+ years) in a cGMP or regulated industry is required.

• Individuals with duties specific to Microbiology data management: 3+ years in a Microbiology Lab is required.

• Experience in OTC Drug / Cosmetic / Medical Device manufacturing strongly preferred.

• Ability to read, write, and understand English.

• Must be able to work with a very high degree of integrity, accuracy, and attention to detail.

• Excellent verbal and written communication skills.

• Working knowledge of Good Manufacturing Practices (21 CFR 210, 211) and Good Documentation Practices.

• Understanding of mathematical concepts such as fractions and percentages in addition to basic math skills.

• Strong decision-making and judgement skills with the ability to identify and address quality issues promptly.

• Ability to handle, organize and prioritize multiple tasks simultaneously and able to perform under pressure to meet deadlines.

• Self-motivated and strong team player, able to work under minimal supervision and partner with other departments.

• Intermediate skills and experience with Microsoft Outlook, Word, and Excel, and TEAMS.

• Proficiency with other databases such as SAP and Quality Management System Software solutions.

• Excellent time management, prioritization, and organization skills with the ability to work productively under minimal supervision

Physical Requirements

• Regularly / Frequently required to sit, stand, and walk, and occasionally required to stoop or kneel.

• Regularly / Frequently required to reach with hands and arms

• Regularly / Frequently use hands to keyboard or type, handle materials or manipulate tools.

• Frequently lift and/or move up to 25 pounds and occasionally up to 50 pounds.

• Vision abilities required including close vision, peripheral vision, depth perception, color vision, and ability to adjust focus.

Work Environment

• Regularly required to wear appropriate personal protective equipment.

• Regularly require to work in production environment including variable noise levels

• Must have high consciousness for personal and equipment safety.