Quality Assurance Specialist

About Forma

Forma is an innovative Contract Development and Manufacturing Organization (CDMO) situated in Irvine, California. Established as a newly independent entity through acquiring BioDuro's Irvine operations, Forma employs approximately 60 dedicated professionals focusing on drug product development and manufacturing services for pharmaceutical and biotech clients.

The company prides itself on a lean and entrepreneurial culture that prioritizes hands-on involvement and swift execution. Teams collaborate closely across departments to address complex technical and operational challenges, ensuring the delivery of consistently high-quality outputs. Team members are encouraged to assume significant responsibilities, engage directly with both colleagues and clients, and contribute to building scalable systems as the organization expands.

Role Overview and Responsibilities

• Lead the review and approve all production batch records, ensuring completeness and accuracy.
• Liaise with clients to secure approvals of batch records and manage client communications.
• Collaborate with cross-functional teams to guarantee prompt resolution of batch-related deviations.
• Assist Supply Chain and Materials Management by assigning material codes, reviewing and approving raw material and packaging specifications, and overseeing material disposition.
• Ensure raw material and service suppliers are vetted and approved per the vendor management policies.
• Participate in and support internal, external audits, and regulatory inspections to maintain compliance readiness for all GMP activities.
• Provide hands-on analytical review and approval of testing data including in-process, release, stability, method validation, cleaning validation, and environmental monitoring, ensuring all tasks meet deadlines.
• Engage in laboratory investigations and follow through on corrective and preventive actions.
• Manage quality exceptions by reviewing and approving deviations, CAPA, non-conformances, risk assessments, and change controls.
• Adhere strictly to safety protocols, particularly related to mechanical, electrical, and fire hazards within manufacturing and lab environments.
• Perform additional duties as assigned by supervisors or quality leadership and remain flexible to role changes.

Required Qualifications

• A bachelor's degree in a science-related discipline is preferred.
• At least five years of professional experience in Quality Assurance.
• Proven expertise in production line clearance, reviewing and approving master/executed batch records, and managing deviations and corrective/preventive measures.
• Working knowledge of CFR, ICH, and GMP standards.
• Strong capability to uphold and enforce GMP compliance across all job functions.
• Exceptional attention to detail in all work activities.
• Excellent written and verbal communication skills.

Preferred Qualifications

• Meticulous attention to detail and quality.
• Positive attitude with strong work ethics and natural leadership qualities.
• Possession of an advanced degree or relevant professional certification.
• Highly effective communication skills, both written and spoken.

Benefits

Forma offers comprehensive health insurance, paid vacation and sick leave, a competitive bonus plan, and salaries aligned with the market. Employees also benefit from various engaging company events fostering team spirit and professional growth.

The compensation range for this position is between $71,000 and $85,000 annually, with actual salary determined by the candidate’s experience, credentials, and fit with the role.