Quality Systems Specialist

Quality Systems Specialist

GSMS - 3.4

Camarillo, CA Job Details $65,000 - $70,000 a year 6 days ago Benefits Health insurance Qualifications Project team coordination Regulatory inspections Statistics Stability testing Record keeping Document review (document control) ISO standards Engineering Process improvement GMP Mid-level 3 years Statistical analysis Bachelor's degree in engineering Bachelor's degree Packaging LMS Quality systems Cross-functional collaboration Document management systems Communication skills Project scheduling Cross-functional communication Progress tracking (project management tasks) FDA regulations Engineering validation New product launch experience Full Job Description Quality Systems Specialist Summary 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 c

GMP, 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 c

GMP, 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.