Quality Systems Specialist

The Quality Systems Specialist plays a critical role in supporting and maintaining the integrity of the Quality Management System (QMS). This position is responsible for coordinating and executing a wide range of quality system activities including product quality assessments, investigations, validation support, and cross-functional project coordination. The ideal candidate will have a strong understanding of cGMP, ISO standards, and regulatory requirements, and will be highly organized, detail-oriented, and collaborative

Product Quality & Engineering Support

• Review SDS, stability data, and component specifications for new product introductions.
• Coordinate New Product Launch (NPL) activities including packaging configuration, product quality assessments, and supplier communication.
• Support facility equipment assessments and regulatory documentation reviews.

• Generate, review, and approve validation protocols and reports.
• Collaborate with cross-functional teams to ensure validation activities meet regulatory and internal requirements.
• Maintain validation documentation and support audits and inspections related to validation.

• Lead and support quality-related projects including process improvements, system upgrades, and product launches.
• Coordinate timelines, deliverables, and communication across departments.
• Track progress, identify risks, and ensure timely completion of project milestones.

• Perform DCR/ECR coordination, including troubleshooting, training, and CRB meeting facilitation.
• Maintain and update CRB slide decks and support change control documentation.
• Review and revise product specifications (bulk and finished goods) and artwork/label specs.
• This position may be assigned additional responsibilities at the discretion of management to support evolving departmental needs and organizational objectives.

• Bachelor’s degree in Life Sciences, Engineering, or related field.
• 3+ years of experience in Quality Assurance, Quality Systems, or related role in a regulated industry.
• Strong knowledge of cGMP, ISO 13485, and FDA regulations.
• Experience in validation protocol generation, review, and approval.
• Demonstrated project management skills in a cross-functional environment.
• Proficiency with electronic systems such as LMS, document control platforms, and change control systems.

• Experience with product lifecycle management (PLM) and new product launch processes.
• Familiarity with statistical analysis for stability assessments and packaging evaluations.
• Prior experience with deviation and complaint investigations.
• Exceptional attention to detail and organizational skills.
• Strong written and verbal communication.
• Ability to manage multiple priorities and meet deadlines.
• Collaborative mindset with a proactive approach to problem-solving.
• Office-based with occasional work in controlled environments (e.g., document rooms, inspection areas).
• Must be able to pass screening, drug test and background check. Adhere to company’s drug-free workplace policies.
• Individual must be enthusiastic, concerned with job and company as whole.
• Self-disciplined with a desire to achieve results.
• Must be detail oriented.
• Team player, professional, and capable of achieving high quality results.
• Comfortable receiving and delivering direct, constructive feedback in pursue of excellence

The hiring range for this position in Camarillo, CA is $65,. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills and experience among other factors. A bonus may be provided as part of the compensation package, in addition to a full range of other health and welfare benefits.