QUALITY OPERATIONS SPECIALIST

20BLOC; Thousand Oaks (CA); On-site; USD 82,000 - 109,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k)

Paid time off

Job summary

A biopharmaceutical company in Thousand Oaks, California is seeking a Quality Operations Specialist. The role encompasses ensuring GMP compliance, supporting batch documentation review, and collaborating with cross-functional teams. Ideal candidates will have a Bachelor's degree in Life Sciences and 4+ years of experience in Quality Assurance. Competitive compensation and benefits are offered along with a full-time, on-site work environment.

Qualifications

• 4+ years of experience in Quality Assurance within a GMP-regulated environment.
• Hands-on experience with batch record review and analytical data review.
• Experience managing deviations, change control, and SOPs.
• Familiarity with regulatory requirements (e.g., FDA, EMA).

Responsibilities

• Review and approve manufacturing batch records and analytical data.
• Initiate and document deviations, including CAPA development.
• Support internal audits and regulatory inspections.
• Collaborate with cross-functional teams to resolve quality issues.

Skills

Quality Assurance

GMP compliance

Root cause analysis

Documentation skills

Analytical data review

Organizational skills

Collaboration

Effective communication

Education

Bachelor’s degree in Life Sciences or a related field

Tools

Electronic QMS systems

Job description

Located in Thousand Oaks, California, 20BLOC is a small privately held development-stage biopharmaceutical company, driven by a mission to create breakthrough protein-based drugs to save lives. Our lead product is an innovative solution to provide oxygen to tissues. Check us out at www.20bloc.com.

We are looking for a motivated and hands-on Quality Operations Specialist to join our team.

How you will add value to 20BLOC

The Quality Operations Specialist supports the Quality Assurance function by ensuring compliance with Good Manufacturing Practice (GMP) requirements. This role is responsible for review and approval of batch documentation and analytical data, management of quality events, and support of the Quality Management System (QMS). The Quality Operations Specialist works closely with Manufacturing, QC, and other cross-functional teams to ensure product quality, data integrity, and regulatory compliance.

Key Responsibilities

GMP Documentation & Review

• Review and approve manufacturing batch records for accuracy, completeness, and GMP compliance (ALCOA+)
• Review analytical data, test results, and associated documentation to support batch disposition
• Support batch release activities in accordance with internal procedures and regulatory requirements

Quality Systems

• Initiate, investigate, and document deviations, including root cause analysis and CAPA development
• Manage and support change control activities, including impact assessments and approvals
• Support SOP lifecycle activities including drafting, review, revision, and implementation
• Ensure documentation practices comply with data integrity and GMP requirements

Compliance & Continuous Improvement

• Support internal audits and regulatory inspections, including preparation of documentation and responses
• Assist in tracking and trending quality events and quality metrics
• Support risk assessments and continuous improvement initiatives
• Ensure timely closure of deviations, CAPAs, and change controls

Cross-Functional Support

• Collaborate with Manufacturing, QC, and other departments to resolve quality issues
• Provide GMP guidance and support to operational teams
• Participate in training activities related to GMP and quality procedures

Education

• Bachelor’s degree in Life Sciences or a related field

Experience

• 4 years+ of experience in Quality Assurance within a GMP-regulated pharmaceutical environment
• Hands-on experience with batch record review and analytical data review
• Experience managing deviations, change control, and SOPs
• Familiarity with regulatory requirements (e.g., FDA, EMA, ICH guidelines)
• Strong understanding of GMP and pharmaceutical quality systems
• High attention to detail and strong documentation skills
• Ability to investigate issues and perform root cause analysis
• Strong organizational and time management skills
• Effective written and verbal communication skills
• Ability to work independently and collaboratively in a team environment
• Proficiency with electronic QMS systems is an advantage

Please apply at [e-mail] – in subject line: Quality Operations Specialist

This is a full‑time, on‑site position located in Thousand Oaks, California, and requires working on‑site Monday through Friday. All applicants must be authorized to work in the United States. We are not sponsoring employment visas.

Compensation: The salary range for this position is $82,000.00. to $109,00.00 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location.

20BLOC is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or other applicable legally protected characteristics.

We offer competitive compensation and benefits including health, dental, vision and life insurance, 401(k) and paid time off.