BEPC Inc. - Business Excellence Professional Consulting
Quality Assurance Specialist
BEPC Inc. - Business Excellence Professional Consulting, Hillsboro, Oregon, United States, 97104
Direct message the job poster from BEPC Inc. - Business Excellence Professional Consulting
Quality Assurance Specialist I – Hillsboro, OR (Contract)
Bepc, Inc has an open position for a Quality Assurance Specialist I in Hillsboro, OR. W2 Contract 12 months with the possibility of extensions Overview
Hillsboro Innovative Therapies (HIT) is seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team. This role focuses on ensuring the quality and compliance of direct materials used in innovative therapy manufacturing processes and performing batch record reviews to support timely product release. The successful candidate will maintain the Quality Management System (QMS) and uphold GMP standards in a fast-paced environment. Responsibilities
Direct Material Introduction & Lifecycle Management: lead QA review and approval of Direct Material (DM) introduction documentation, including material specifications, supplier questionnaires, and technical data packages; collaborate with cross-functional teams to qualify and implement new direct materials in compliance with procedures and regulatory requirements; participate in material risk assessments to identify, evaluate, and mitigate quality and regulatory risks; review and approve supplier qualification documentation (audit reports, quality agreements) for direct material suppliers; ensure DMs comply with GMP, pharmacopoeial requirements (USP, EP), and material-related guidelines (e.g., TSE/BSE, Extractables & Leachables, REACH/SVHC); support maintenance of direct material master data in ERP and QMS. Batch Record Review & Product Release Support: perform timely review of executed batch records for manufacturing, packaging, and testing; identify, document, and escalate discrepancies and deviations with thorough investigations; verify adherence to Master Batch Records, SOPs, and GMP; collaborate with Manufacturing and Quality Control to resolve issues and ensure documentation supports timely product release. General Quality Assurance Responsibilities: initiate/investigate deviations, non-conformances, and OOS results, participate in root cause analysis (RCA) and CAPA development; review change control requests (Planned Events) for impact on validated systems and processes; participate in internal/external audits and inspections; contribute to continuous improvement within the QMS. Qualifications
Education: Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Microbiology, Pharmacy, Biotechnology, or related field). Experience: Minimum 3–5 years of direct Quality Assurance experience within a GMP-regulated pharmaceutical or biotechnology manufacturing environment; demonstrated experience with direct material qualification processes; proven experience in batch record review for pharmaceutical or biological products. Knowledge, Skills, and Abilities: strong knowledge of cGMP regulations (FDA 21 CFR Parts 210, 211; Eudralex Volume 4; ICH guidelines); familiarity with pharmacopoeial requirements (USP, EP) related to raw materials and finished products; excellent attention to detail, analytical and problem-solving skills; excellent written and verbal communication; ability to work independently, manage multiple priorities, and meet deadlines; strong collaboration across cross-functional teams; proficiency in QMS software (e.g., Veeva Vault QualityDocs/QMS) and ERP systems (e.g., SAP). Preferred Qualifications: experience with Cell and Gene Therapy (CGT) products or other innovative therapies; familiarity with material-related regulations or guidelines (e.g., ISO standards for medical devices, chemical legislation); experience with risk management tools (e.g., FMEA, PHA); QA certifications (e.g., ASQ CQA, CQE). Why Join HIT?
At Hillsboro Innovative Therapies (HIT), you’ll be part of a pioneering team dedicated to developing and manufacturing life-changing innovative therapies. We offer a challenging yet rewarding environment where your expertise directly contributes to patient well-being. Join us in shaping the future of medicine through scientific excellence and an unwavering commitment to quality. Additional Information
Seniority level: Mid-Senior level Employment type: Contract Job function: Quality Assurance Industries: Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at BEPC Inc. - Business Excellence Professional Consulting by 2x. We are not including any information about closed positions in this description.
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Bepc, Inc has an open position for a Quality Assurance Specialist I in Hillsboro, OR. W2 Contract 12 months with the possibility of extensions Overview
Hillsboro Innovative Therapies (HIT) is seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team. This role focuses on ensuring the quality and compliance of direct materials used in innovative therapy manufacturing processes and performing batch record reviews to support timely product release. The successful candidate will maintain the Quality Management System (QMS) and uphold GMP standards in a fast-paced environment. Responsibilities
Direct Material Introduction & Lifecycle Management: lead QA review and approval of Direct Material (DM) introduction documentation, including material specifications, supplier questionnaires, and technical data packages; collaborate with cross-functional teams to qualify and implement new direct materials in compliance with procedures and regulatory requirements; participate in material risk assessments to identify, evaluate, and mitigate quality and regulatory risks; review and approve supplier qualification documentation (audit reports, quality agreements) for direct material suppliers; ensure DMs comply with GMP, pharmacopoeial requirements (USP, EP), and material-related guidelines (e.g., TSE/BSE, Extractables & Leachables, REACH/SVHC); support maintenance of direct material master data in ERP and QMS. Batch Record Review & Product Release Support: perform timely review of executed batch records for manufacturing, packaging, and testing; identify, document, and escalate discrepancies and deviations with thorough investigations; verify adherence to Master Batch Records, SOPs, and GMP; collaborate with Manufacturing and Quality Control to resolve issues and ensure documentation supports timely product release. General Quality Assurance Responsibilities: initiate/investigate deviations, non-conformances, and OOS results, participate in root cause analysis (RCA) and CAPA development; review change control requests (Planned Events) for impact on validated systems and processes; participate in internal/external audits and inspections; contribute to continuous improvement within the QMS. Qualifications
Education: Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Microbiology, Pharmacy, Biotechnology, or related field). Experience: Minimum 3–5 years of direct Quality Assurance experience within a GMP-regulated pharmaceutical or biotechnology manufacturing environment; demonstrated experience with direct material qualification processes; proven experience in batch record review for pharmaceutical or biological products. Knowledge, Skills, and Abilities: strong knowledge of cGMP regulations (FDA 21 CFR Parts 210, 211; Eudralex Volume 4; ICH guidelines); familiarity with pharmacopoeial requirements (USP, EP) related to raw materials and finished products; excellent attention to detail, analytical and problem-solving skills; excellent written and verbal communication; ability to work independently, manage multiple priorities, and meet deadlines; strong collaboration across cross-functional teams; proficiency in QMS software (e.g., Veeva Vault QualityDocs/QMS) and ERP systems (e.g., SAP). Preferred Qualifications: experience with Cell and Gene Therapy (CGT) products or other innovative therapies; familiarity with material-related regulations or guidelines (e.g., ISO standards for medical devices, chemical legislation); experience with risk management tools (e.g., FMEA, PHA); QA certifications (e.g., ASQ CQA, CQE). Why Join HIT?
At Hillsboro Innovative Therapies (HIT), you’ll be part of a pioneering team dedicated to developing and manufacturing life-changing innovative therapies. We offer a challenging yet rewarding environment where your expertise directly contributes to patient well-being. Join us in shaping the future of medicine through scientific excellence and an unwavering commitment to quality. Additional Information
Seniority level: Mid-Senior level Employment type: Contract Job function: Quality Assurance Industries: Biotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at BEPC Inc. - Business Excellence Professional Consulting by 2x. We are not including any information about closed positions in this description.
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