The Position

Position Summary

Hillsboro Innovative Therapies (HIT) is seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our dynamic team. This critical role will primarily focus on ensuring the quality and compliance of direct materials used in our cutting-edge innovative therapy manufacturing processes and performing thorough batch record reviews to support timely product release. The successful candidate will play a pivotal role in maintaining our robust Quality Management System (QMS) and upholding the highest GMP standards in a fast-paced and evolving environment.

In this role, you will be an employee of Tailored Management, working on a Genentech contract.

Shift: Monday to Friday, 8:00am to 4:30pm

Pay rate: $35 to $55/hour (Depends on Experience)

Conract duration: 12 months (possible extensions up to 36 months)

Key Responsibilities

1. Direct Material Introduction & Lifecycle Management:

• Lead Quality Assurance review and approval of Direct Material (DM) introduction documentation, including material specifications, supplier questionnaires, and technical data packages.
• Collaborate extensively with cross-functional teams (e.g., Procurement, Manufacturing Science and Technology, Manufacturing, Quality Control, Supply Chain) to ensure new direct materials are selected, qualified, and implemented in compliance with internal procedures and regulatory requirements.
• Participate in material risk assessments, ensuring potential quality and regulatory risks associated with new DMs are identified, evaluated, and appropriately mitigated.
• Review and approve supplier qualification documentation, including audit reports and quality agreements, specifically for direct material suppliers.
• Ensure DMs comply with relevant GMP regulations, pharmacopoeial requirements (e.g., USP, EP), and specific material-related guidelines (e.g., TSE/BSE, Extractables & Leachables, chemical legislation like REACH/SVHC).
• Support the creation and maintenance of direct material master data within the Enterprise Resource Planning (ERP) and Quality Management Systems.

2. Batch Record Review & Product Release Support:

• Perform comprehensive and timely review of executed batch records for manufacturing, packaging, and testing operations of innovative therapy products.
• Identify, document, and escalate discrepancies, deviations, errors, and omissions in batch records, ensuring thorough investigation and timely resolution in collaboration with Manufacturing and Quality Control.
• Verify strict adherence to approved Master Batch Records, Standard Operating Procedures (SOPs), and Good Manufacturing Practices (GMP) throughout the batch execution.
• Collaborate closely with Manufacturing and Quality Control personnel to facilitate efficient resolution of batch-related issues and ensure accurate documentation.
• Support the timely release of drug product batches by ensuring all associated documentation is complete, accurate, and compliant with regulatory filings and internal specifications.

3. General Quality Assurance Responsibilities:

• Initiate, investigate, and/or review deviations, non-conformances, and Out-of-Specification (OOS) results, including participation in root cause analysis (RCA) and the development of effective corrective and preventive actions (CAPA).
• Review and approve change control requests (Planned Events), ensuring proper assessment of impact on validated systems, processes, equipment, and products.
• Participate in and support internal and external audits/inspections (e.g., regulatory agency inspections, customer audits), providing necessary documentation and follow-up on findings.
• Contribute to continuous improvement initiatives within the Quality Management System (QMS) to enhance efficiency and effectiveness.

Qualifications

Education:

• Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Microbiology, Pharmacy, Biotechnology, or related field).

Experience:

• Minimum of 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 current Good Manufacturing Practices (cGMP) regulations (e.g., FDA 21 CFR Parts 210, 211, Eudralex Volume 4, ICH guidelines).
• Familiarity with pharmacopoeial requirements (e.g., USP, EP) related to raw materials and finished products.
• Excellent attention to detail and strong analytical and problem-solving skills.
• Exceptional written and verbal communication skills, with the ability to clearly articulate complex quality concepts to diverse audiences.
• Ability to work independently, manage multiple priorities, and meet deadlines in a fast-paced, dynamic environment.
• Strong interpersonal skills and the ability to collaborate effectively with cross-functional teams.
• Proficiency in Quality Management Systems (QMS) software (e.g., Veeva Vault QualityDocs/QMS) and Enterprise Resource Planning (ERP) systems (e.g., SAP).

Preferred Qualifications

• Experience with Cell and Gene Therapy (CGT) products or other innovative therapies.
• Familiarity with specific material-related regulations or guidelines (e.g., ISO standards for medical devices, specific chemical legislation).
• Experience with risk management principles and tools (e.g., FMEA, PHA).
• Certifications in Quality Assurance (e.g., ASQ Certified Quality Auditor, Certified Quality Engineer).

Why Join Hillsboro Innovative Therapies (HIT)?

At 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 unwavering commitment to quality.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.