MCS Senior Associate Quality Control - Hybrid

MCS Senior Associate Quality Control

Location: Thousand Oaks, CA. 91367 (Hybrid/Mostly Remote)

Employment Type: Contract

Business Unit: ATO Quality Control

Duration: 1+ years (with likely extensions)

Notes: Only qualified candidates, please. Remote but may be required to go onsite from time to time

Job Description

With minimal supervision the preferred candidate will have the following responsibilities:

• Generation of Certificate of Analysis for Raw Materials and Manufacturing release samples. This will include using SM LIMS to release lots in support of disposition
• Monitoring of testing within Quality Control Labs against due dates
• Facilitate Contract Laboratory testing in support of release of Product and Raw Materials which will include but not limited to:
  • Following up on testing that is in progress
  • Monitoring of testing
  • Entering results and coordinating approval of results
  • Managing documentation in quality systems to support testing and release which may include using CDOCS
• Dynamic work hours to support release of product
• Support generation of SM LIMS packets/labels for Manufacturing
• General sample management support which may include, logging, labeling and processing of samples
• Minor deviation ownership as required

Basic Qualifications

Bachelor's degree and 2 years of Quality Control, Quality Assurance or related experience OR Associate's degree and 6 years of Quality Control, Quality Assurance or related experience OR High school diploma / GED and 8 years of Quality Control, Quality Assurance or related experience

Preferred Qualifications

• Ability to adhere to regulatory requirements, written procedures and safety guidelines
• Ability to evaluate documentation/data according to company and regulatory guidelines
• Ability to organize work, handle multiple priorities and meet deadlines
• Strong written and oral communication skills
• Must be detail orientated
• Must be flexible and adaptable to changing priorities and requirements
• Demonstrate understanding of regulatory requirements, safety guidelines and factors impacting compliance
• Demonstrates understanding of when and how to appropriately escalate
• May identify, recommend and implement improvements related to routine job functions
• Must learn and comply with safety guideline and cGMPs

Why is the Position Open?

Supplement additional workload on team.

Top Must-Have Skill Sets

• Customer Service
• Attention to Detail
• QC experience
• LIMS experience
• Some lab experience (This is not a lab position)

Day to Day Responsibilities

This is NOT a lab position. Understand how the lab operate or general understanding of some methods is helpful. This position will work with the ATO sites and other client sites to facilitate the testing and approval of contract lab testing to support release of raw materials and product. This will include following up with the labs to ensure testing will be completed on time, entering results when testing is complete and working with other staff to ensure results are approved with no impact to production or release. This staff will also support the Sample Coordination area with issuing certificates of analysis when testing is completed by both internal labs and contract labs.

Employee Value Proposition

The person in this role will have the opportunity to see the entire process from start to finish. You will see samples from raw materials through drug product and work with multiple sites and labs.

Red Flags

The staff only wants to work in the lab.

Interview Process

Phone screening followed by in-person interview.

We invite qualified candidates to send your resume to View email address on click.appcast.io . If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.