Sr Associate QA (JP5195)

Location: Thousand Oaks, CA
Date Posted: 01-11-2019
Job Title: Sr Associate QA (JP5195)
Location: Thousand Oaks, CA
Employment Type: Contract
Duration: 16 months with likely extensions
 
3Key Consulting is looking for an Sr Associate QA for a leading, international pharmaceutical company headquartered in Thousand Oaks, CA.
 
Job Summary:  
Under minimal supervision, the Senior Associate Plant Quality Assurance is primarily responsible for performing quality review of documentation to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations. Duties focus on providing quality guidance during on-the-floor manufacturing activities. 

***SHIFT HOURS***IMPORTANT 

This position will begin with regular M-F 8-5 hours then once the worker is fully trained (approx..2-3 months) there may be a chance they are moved to either a tues-sat shift or a sun-thurs shift with any of these possible sift times: 8am-5pm, 6am-3pm 12pm-10pm. So if your candidate has many obligations outside of work or specific scheduling requests and they are not flexible and willing to work ANY of the above shifts, then they will NOT be a good candidate for this role. They must be able to take on any of the above shifts. 

Day-To-Day Responsibilities:

§ Author/review quality documents, such as: SOPs and Batch Records (electronic and paper-based) 
o Execute daily operations per management guidance in a dynamic environment. 
o Perform On-The-Floor (OTF) quality review of documents, such as: equipment logs, training records, testing results, batch records and supporting documents. 
o Perform daily OTF inspections to ensure facilities, equipment, materials and documentation comply with SOPs and safety standards. 
o Provide guidance during on-the-floor manufacturing and testing. 
o Support audits, inspections and investigations. 
o Adhere to LEAN practices and contribute to culture of continuous improvement. 

Basic Qualifications: 

o Master's Degree OR o Bachelor's Degree and 2 years of Quality experience o OR o Associate's degree and 6 years of Quality experience o OR o High school diploma/GED and 8 years of Quality experience 

Preferred Qualifications: 
o Strong cGMP and GDP behaviors 
o Demonstrated experience with deviations and CAPA records 
o Previous experience supporting GMP facilities. 
o Knowledge of electronic systems including LIMS, Trackwise, and Maximo 
o Strong organizational skills and ability to manage multiple tasks at one time 
o Ability to follow assignments through to completion and meet timelines 
o Exposure to regulatory agency inspectors or participation in regulatory agency audits. 
o Strong technical communication skills, both written and oral 
o Demonstrated ability to work as a team player and independently
 
Top Must have Skill Sets:
1. Strong cGMP and GDP behaviors
2. Previous experience supporting GMP facilities
3. Strong organizational skills and ability to manage multiple tasks at one time
4. Worked in bio-pharma company/ Manufacturing environment
 
Employee Value Proposition: Along with Amgen being a well established company to join, this team has a few exciting projects in the pipeline so it is an exciting time for this team and function at Amgen.
 
Red Flags:
  • Bad communication skills.
  • Unable to  work in a team
  • Unable to work weekends or not flexible in their schedule *IMPORTANT*
 Interview Process: Interview approximately 5 In-person interviews and I am available as soon as possible.
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.**No Third-party Vendors Please**
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Regards,
 
3KC Talent Acquisition Team
 
 
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