Specialist, Quality Control - Microbiologist (Contract Role)

About the role

Orca Bio is a late-stage biotechnology company focused on developing next-generation cell therapies to treat blood cancers. This Specialist, Quality Control - Microbiologist position plays a crucial role in ensuring the quality and safety of these therapies through meticulous management of quality systems.

Responsibilities

• Oversee the management of quality systems including deviations, change controls, CAPAs, and document control.
• Investigate and implement corrective actions for deviations to ensure compliance with regulatory requirements and internal procedures.
• Review and approve change controls to maintain compliance with regulatory standards and internal procedures.
• Maintain and improve CAPA processes to ensure effective resolution of quality issues.
• Evaluate batch records and associated documentation to make informed batch release decisions.
• Collaborate with manufacturing and quality control teams to ensure all products meet regulatory and quality standards before release.
• Monitor and document any quality issues related to batch production and implement corrective measures as necessary.
• Maintain the document management system to ensure all quality-related documents are accurate, current, and compliant with regulatory standards.
• Stay informed of current regulations, industry trends, and best practices in pharmaceutical quality assurance.
• Aid in preparing for internal and external audits, ensuring that all quality systems and documentation are audit-ready.
• Provide training and guidance to staff on quality systems, processes, and compliance requirements.
• Serve as a point of contact for quality-related inquiries and issues, fostering a culture of quality within the organization.
• Participate in continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes.
• Identify areas for improvement within quality operations and suggest appropriate solutions.
• Track completion of quality records and maintain metrics.
• Perform other duties as requested by supervisor/manager to support Quality.

Qualifications

• Bachelor’s degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) with 3+ years of experience in quality control testing, analytical development, or GMP; OR a Master’s degree in relevant scientific disciplines with 1+ years of experience.
• Understanding of FDA regulations, GMP compliance, and quality system processes.
• Experience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred.
• Detail-oriented with a commitment to data integrity and accuracy, and an ability to identify problems with data management.
• Able to work collaboratively to respond to changing priorities and challenges.
• Able to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment.

Skills

• Strong organizational skills and the ability to manage multiple tasks concurrently.
• Effective communication and collaboration with cross-functional teams.
• Willingness to learn and adapt in a fast-paced, dynamic environment.
• Adherence to cGMP policies and procedures, including documentation activities.
• Able to work collaboratively to respond to changing priorities and challenges.
• Able to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment.

Benefits

Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.

Pay

$36 - $43 an hour

Schedule

Approximately 6 months (July-December)