This page was automatically translated and may contain errors. View in English.

Quality Assurance Release Specialist

The Goodkind Co, a Certified B-Corp

Round Rock, TX · 정규직

가장 먼저 지원하세요

경험
3년 이상
샐러리
채용 공고
1
게시됨
5시간전
작업 모드
사무실에서
교육
학사 학위
재개하다
신청 시 필수 사항

당신이 일하게 될 곳

직무 설명

Overview

The Quality Assurance Release Specialist, reporting to the QA Supervisor, oversees batch disposition and quality system operations to confirm products satisfy internal standards, customer expectations, and regulatory mandates before market release. This role emphasizes risk-informed judgments and technical assessment of manufacturing, quality, and compliance data to facilitate product release, investigations, and ongoing improvements.

About The Goodkind Co

Established in 2010 near Austin, Goodkind is a prominent manufacturer specializing in natural and environmentally conscious personal care and beauty items, including deodorants, skincare, and facial products. The company expertly formulates products in line with standards from organizations such as Ecocert, EWG, and retailers like Credo and Sephora. As a certified B Corporation, Goodkind balances profit and purpose by factoring in the well-being of associates, customers, suppliers, community, and environment to deliver sustainable value.

Key Responsibilities

  • Examine and authorize batch production documents and quality records before product release.
  • Assess manufacturing and quality data to detect deviations, trends, and potential risks impacting product quality.
  • Handle and support investigations concerning non-conformance reports (NCRs), deviations, and Corrective and Preventive Actions (CAPA).
  • Assist in change control activities including evaluating quality impacts and risks.
  • Review Certificates of Analysis and product specifications to approve releases.
  • Verify calibration status and quality system compliance before batch disposition.
  • Identify recurring quality issues through data analysis and trend monitoring to back continuous improvements.
  • Escalate risks affecting product disposition or regulatory adherence.
  • Work closely with QA, QC, Manufacturing, and Operations teams to resolve quality system challenges.
  • Maintain complete, accurate, and audit-ready quality documentation.
  • Support internal/external audits and regulatory inspections.
  • Undertake any additional duties as assigned.

Qualifications and Requirements

  • Bachelor’s degree in Chemistry, Biology, Engineering, Life Sciences, or related discipline, or equivalent work experience.
  • Minimum three years of experience in Quality Assurance within regulated manufacturing environments.
  • Comprehensive knowledge of GMP standards and quality management systems.
  • Experienced in batch record evaluation and product release processes.
  • Proficient managing deviations, NCRs, CAPA, and change controls.
  • Skilled in root cause analysis and risk-based decision making.
  • Competent in reviewing manufacturing and quality compliance data.
  • Excellent communication capabilities, both written and verbal.
  • Strong attention to detail, organizational skills, and diligent documentation practices.
  • Capable of independently managing multiple tasks in a dynamic setting.

Preferred Skills and Experience

  • Background in over-the-counter (OTC), pharmaceutical, cosmetic, or personal care product manufacturing.
  • Familiarity with ERP systems, electronic Quality Management Systems (eQMS), and Redzone software.
  • Understanding of FDA regulations, ISO standards, and data integrity concepts.
  • Experience supporting audits, regulatory inspections, and validation processes.

Key Competencies

  • Informed batch release and disposition decision-making.
  • Proficient root cause investigations and risk evaluations.
  • Management of quality systems including NCRs, CAPA, deviations, and change control.
  • Data analytical skills and trend evaluation expertise.
  • Regulatory compliance with strong GMP knowledge.
  • Critical thinking and problem resolution abilities.
  • Effective cross-functional collaboration skills.
  • Expertise in technical documentation and investigative report writing.
  • Strong accountability and sound judgment.

답변을 원하시면 남겨주세요. 다른 용도로는 사용하지 않습니다.

클릭하여 살펴보세요드래그 앤 드롭 또는 반죽 스크린샷

PNG, JPG, GIF, MP4, WebM, MOV · 파일당 최대 20MB · 최대 5개 파일

🤖
온라인 · 즉각적인 AI 도움말