You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.
Job Summary
Our client is seeking a Quality Assurance Coordinator to coordinate the cross-functional management and execution of required activities within designated area(s) of the Quality Management System (QMS). The primary responsibilities include approving batches for release, supporting document control, driving the execution of QMS processes, and participating in external audits.
Key Responsibilities
- Approve batches for release by inspecting production records and ensuring compliance with established procedures.
- Track non-standard batch numbers to ensure conformance with procedures.
- Support the document control process throughout its cycle.
- Drive daily management for related QMS processes and implement improvements.
- Support the assignment and verification of trouble reports.
- Participate in CAPA investigations and nonconformity process activities as needed.
- Prepare and submit standard reports, KPI data, and Management Review data.
- Participate in external audits as a subject matter expert for QMS processes.
- Manage the response to audit non-conformities and provide QMS training.
- Engage in GQM improvement activities including high priority projects.
Qualifications
- 3+ years of experience in a regulated industry (Med Device, Food, Drug, etc).
- Demonstrated understanding of Quality Management System requirements (ISO, FDA, GMP, etc).
- Working knowledge of standard work/SOPs.
- Skills with QC tools & techniques is preferred but not required.
- Ability to communicate effectively with peers and engage in problem-solving activities.
- Experienced in technical report writing and possess analytical skills.
- Skilled in Microsoft 365 tools and technology.
Experience
- 3+ years of related Quality Management System experience.
- Quality certification (ASQ, etc.) is a plus.
Education
- BA/BS Degree in science, engineering, or related field is preferred.
- Equivalent experience in Quality related or adjacent role will be considered.
Benefits
- Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances).
- Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)).
- 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1).
- Short Term Disability Insurance.
- Term Life Insurance Plan.
*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).
Medix Overview:
With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.
*As a job position within our Life Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk work environments (warehouse or industrial areas), high-risk/ high-error job duties that could result in life-threatening injury or death, operation of heavy-duty machinery, working with hazardous chemicals, exposure to other dangerous materials, such as drugs and sharp instruments. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.
