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 an experienced Systems Specialist to support Quality Management Systems including Annual Product Review (APR), Management Review, and CAPA processes. The successful candidate will address and escalate Quality Management Systems (QMS) or Compliance issues, and will report to the Senior Manager, Quality Systems and Operational Excellence. This role involves critical thinking and proactively managing quality risks.
Key Responsibilities
- Support collection and analysis of data for APR, Management Review, Quality Metrics, CAPAs, and Investigation trends.
- Monitor key performance indicators (KPI) to identify and mitigate Quality risks.
- Interact with other departments to coordinate QMS activities and data analysis.
- Maintain QMS and escalate issues as required.
- Create, revise, review, approve, and implement QMS procedures.
- Review documents for compliance with company standards.
- Coordinate QMS activities ensuring timely completion.
- Manage Change Control process, including documentation and updates.
- Update and track label revisions.
- Support scanning, reviewing, archiving, and tracking all documents.
- Participate in and support process improvements and projects.
Qualifications
- Experience in FDA-regulated pharmaceutical or 503B Sterile Compounding industry with a background in cGMP processes.
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.
Required Employment / Compliance Language
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
*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.
