Jobs in the United States

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Goodier Cosmetics

Quality Associate III

Dallas, TX, United States

Apply on workforcenow.adp.com About employer

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Job details

Experience: Quality experience (5+ years) in a cGMP or regulated industry.
Posting language: English

Original job description

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 Manager. This position is responsible for ensuring that all products released by Goodier conform to all regulatory and quality specifications. 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

Primary tasks:

Collect, organize, and prepares samples for testing at third party test labs (3PL).
Review Microbiological test reports for accuracy and compliance to specifications.
Input and maintain all microbiological test data in quality databases and/or electronic systems. Executes data trending as requested.
Provide timely completed test documentation for inclusion in batch records to facilitate lot release. Work with Quality and Production teams as needed to drive updates and accurate completion.
Perform batch record review for Bulk Product ensuring complete documentation and GMP compliance and facilitate Bulk lot release.
Perform Environmental Audit testing.
Prepare, organize, document, archive and manage the life cycle of Finished Product retain samples.
Observe and monitor activity in production areas to assure adherence to procedures, Good Manufacturing Practices (cGMPs), and Good Documentation Practices.

Additional tasks may include:

Create and issue Finished Good Lot codes to Production.
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 issues Quality Alerts as required for observed non-conformances.
Support management of Finished Good rework lots and product or components that are on hold.
Perform other duties as assigned.

Qualification requirements

High school diploma or equivalent.
3+ years in a Microbiology Lab is required
Quality experience (5+ years) in a cGMP or regulated industry.
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.

Apply on workforcenow.adp.com About employer

More about this job

Skills

Quality assurance
Regulatory compliance
Electronics
Documentation
Good manufacturing practices
Monitor activities
Inspection
Leadership
Attention to detail
Communication skills
Decision making
Cope with pressure
Meet deadlines
Microsoft Outlook
Microsoft Word
Microsoft Excel
SAP
Quality assurance procedures
Time management
Prioritization
Personal protective equipment

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Work requirements

Jobs in the United States