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
General Duties and Responsibilities:
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.
Validation Activities
- 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.
Project Management
- 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.
Change Control & Quality Records
- 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.
Basic Qualifications and Skills, Knowledge Experience:
Required:
- 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.
Preferred:
- 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.
Key Competencies:
- 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.
Work Environment:
- Office-based with occasional work in controlled environments (e.g., document rooms, inspection areas).
Miscellaneous Requirements:
- Must be able to pass screening, drug test and background check. Adhere to company’s drug-free workplace policies.
Attitude:
- 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 $65,000-70,000. 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.
