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$71k–$85k/yr
Full-time
bachelor degree, postgraduate degree
Full Health Benefits, Paid Vacation, Sick Leave, Bonus Structure, Market-competitive Salaries, Employee Events
Posted 13d ago
~40 hrs/week
Responsibilities
The Specialist manages Quality Assurance activities for materials, manufacturing, and testing to ensure strict compliance with GMP regulatory requirements. Key duties include reviewing batch records, managing deviations and CAPAs, and supporting regulatory inspections and audits.
Requirements
Candidates should have a minimum of 5 years of experience in Quality Assurance with hands-on expertise in production line clearance and batch record approval. A bachelor's degree in a science-related field is preferred, along with working knowledge of CFR, ICH, and GMP regulations.
Full job description
What We Do
Forma is a next-generation Contract Development and Manufacturing Organization (CDMO) based in Irvine, California. The company was recently formed through the acquisition of the Irvine operations from BioDuro and is operating as a newly established, independent entity. As a result, Forma’s standalone online presence is still being built.
We are a lean, entrepreneurial organization of approximately 60 employees focused on drug product development and manufacturing for pharmaceutical and biotechnology clients.
Why Forma?
Unlike large, highly layered organizations, Forma operates with a hands-on, execution-driven model. Our teams work closely across functions to solve complex technical and operational challenges, move quickly, and deliver consistently high-quality results.
Employees at Forma are expected to take on meaningful responsibility, collaborate directly with colleagues and clients, and contribute to building scalable systems and processes as the company grows. This is an environment well suited to individuals who value autonomy, technical excellence, and the opportunity to help shape a growing organization.
Job Overview/Summary
The Specialist supports Quality Assurance activities regarding materials management, manufacturing, testing, packaging, labeling, facilities, and equipment ensures compliance to GMP regulatory requirements.
Essential Functions and Responsibilities
Primary person responsible for review and approval of all batch records.
Work directly with clients to obtain approvals on batch records and client notifications.
Work with cross functional stake holders to ensure timely closure of batch associated deviations.
Supply Chain/Materials Management Support – Support Materials Management in assignment of material codes, review/approval of raw material and packaging component specifications, and materials disposition. Ensure suppliers of raw materials and services are approved according to the vendor management program.
Audits and Regulatory Inspections – Participate and assist with internal and external audits and regulatory inspections. Work with the QA group to ensure inspection-readiness for all GMP operations, including compliance with CFRs, GMPs, company policies and procedures.
Analytical Support – Provide hands-on support for data review/approval of analytical testing data summaries (such as in-process, release, stability, method validation, and cleaning validation/verification testing, environmental monitoring data) and ensure tasks are tracked and timelines are met. Participate in laboratory investigations and ensure corrective and preventive actions are implemented.
Support quality exceptions including review/approval of deviations, CAPA, non-conformances, risk/impact assessment, and change management.
Safety – Comply with all safety regulations and Mechanical/Electrical/Fire Hazards encountered in Manufacturing/Laboratory Areas
Other duties as deemed appropriate by the Supervisor or Head of Quality.
This job description is subject to change at any time.
Required Qualifications
Bachelor’s degree in science-related field is preferred.
Minimum 5 years of experience in Quality Assurance
Hands-on experience performing production line clearance, review/approval master and executed production batch records, review/approval of deviations and implementation of corrective and preventive actions.
Working knowledge of applicable CFR, ICH, and GMP regulations.
Ability to apply and enforce GMP compliance to all aspects of the position.
Detailed attention in job performance.
Excellent written and verbal communication.
Preferred Qualifications
Detailed attention in job performance
Good attitude, work ethic and natural leadership
Achievement of an advanced degree or certification
Excellent written and verbal communication
Position Benefits
We offer full health benefits, paid vacation and sick leave, an aggressive bonus structure, and market-competitive salaries to all our employees. In addition, Forma provides employees with a variety of engaging employee events.
The salary range for this position is $71,000-$85,000 annually. Actual compensation will be determined based on the selected candidate’s experience, qualifications, skills, and overall fit for the role.
Forma is where molecules become medicine.
Formed in 2026 as a next-generation CDMO, we offer formulation development and manufacturing for oral solid dosage programs from early clinical development through commercial manufacturing. Our capabilities are grounded in nearly 30 years of formulation expertise, including deep experience in amorphous solid dispersion and modified release technologies, developed through long-standing operations in Southern California.
Offices: 9601 Jeronimo Rd, Irvine, California 92618, US · 72 Fairbanks, Irvine, California 92618, US
How much do Science & Research jobs in California pay?
Based on 11610 listings with disclosed salaries, most science & research jobs in California pay between $102k–$250k per year. Individual offers vary with seniority, company size, and specialization.
How many Science & Research jobs are open in California right now?
There are currently 18,374 open science & research positions in California listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Science & Research roles in California?
Companies currently hiring include Applied Materials, Northrop Grumman, Google, Apple, Northrop Grumman Mission Systems, Inc., among others. Browse the listings above to see every active employer.
Are there remote or hybrid Science & Research jobs in California?
Yes — 3886 of the 18374 open science & research positions offer remote or hybrid work (979 remote, 2907 hybrid).
How do I apply for Science & Research jobs in California?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.