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 Aseptic Technician to ensure compliance with all current IOPS cGxPs, complete all required training items and uphold inspection readiness. The primary goal is to maintain Safe, Clean, and Compliant (SCC) standards and comply with regulatory requirements for all tasks performed.
Key Responsibilities
- Comply with all current IOPS cGxPs (e.g., Good Manufacturing Processes, Good Documentation Practices).
- Complete all training items within required timeframes before task performance.
- Perform all tasks as per approved standard operating procedures (SOPs).
- Adhere to IOPS Environmental, Health & Safety policies when executing tasks.
- Maintain inspection readiness at all times.
- May work within GxP/quality systems, perform documentation reviews, investigational support, validation activities, and ad hoc Quality Assurance duties.
Skills
- Development, execution, and review of aseptic process simulations.
- Risk-Based Approaches for Aseptic Process Simulations.
- Strategies for Challenge Conditions / Study Requirements for Aseptic Process Simulations.
- Familiarity with FDA CFR, EMA requirements and expectations for Aseptic Process Simulations.
- Familiarity with PDA Technical Reports regarding Aseptic Process Simulations (Preferred).
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
Medix is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity
*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.
