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 Manufacturing QMS Specialist for a full-time exempt position. Under the direction of Manufacturing Management, the Specialist will be responsible for executing routine documentation work, writing, and reviewing deviations, change controls, investigation reports, executed batch records, SOPs, CAPAs, and more. A thorough understanding of drug product manufacturing and packaging, as well as biologics processes, is required.

Key Responsibilities

• Support the manufacturing team with documentation.
• Review executed batch records including Drug Product, Secondary Packaging, and Associated Departments.
• File change controls, Deviations, and CAPAs for the manufacturing department.
• Track and close QMS documents.
• Utilize tools like 5Why or 6M method for major investigation resolutions.
• Coordinate with cross-functional teams for timely closure of investigations and action items.
• Author batch records, SOPs, forms, and formats for manufacturing processes.
• Request and submit all GMP documents to QA.
• Participate in Regulatory inspections and compliance activities.
• Support manufacturing processes during critical campaigns, involving rotating shifts.
• Perform other functions as required or assigned.
• Comply with all company policies and standards.

Qualifications

• Minimum 5 years of experience in Biopharmaceuticals.
• Knowledge in Regulatory Compliance.

Skills

• Good interpersonal skills to work with team members and independently.
• Strong verbal and written communication skills, computer, and organizational skills, attention to detail.
• Basic skills in Word, Excel, and spreadsheets.
• Experience in GMP batch manufacturing and packaging documentation, audit and review.
• Knowledge in cleaning verification/validation.

Additional Requirements

• High-paced demanding environment to meet ambitious project goals.
• No travel required.

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).

This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on 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.

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.