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MCS Senior Associate Quality Control, Biopharma - Remote CA (JP10105)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:   MCS Senior Associate Quality Control, Biopharma - Remote CA (JP10105)
Location: Thousand Oaks, CA. (Mostly remote)
Employment Type:  Contract
Business Unit: 
Quality Control
Duration: 12 months with likely extensions
Posting Date: 4/20/2022
Hybrid role (primarily remote, with purposely onsite) - will be planned come onsite
Local CA candidate, preferred.

3 Key Consulting is hiring MCS Senior Associate Quality Control for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:

Under general supervision, this position will perform routine procedures and in support of Quality Control. This position will be responsible for one or more of the following activities: - Own Analytical Result Assessments in Amgen's Quality system
- Own Minor Deviations in Amgen's Quality system
- Own and/or revise Standard Operating Procedures, Specifications, or other controlled documents using Quality systems
- Assist members of the team with running reports, metrics, and other administrative tasks.

Other more complex tasks may be assigned as proficiency is achieved. This position is considered Flex. The preferred candidate should be able to work remotely and onsite as needed.

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?
Staff Augmentation.

Top Must Have Skills:
  • Skill Preferred: Organized, Attention to Detail
  • 2-3 Quality Control experience
  • Prior General Lab experience
  • Degree with work experience and/or high school graduate with years of experience
  • Nonconformance, documentation experience

Day to Day Responsibilities:
Support the QC organization with owning minor deviations, ARA's and document creation and revision. This staff will need to be able to work with multiple staff both inside the function and our manufacturing and Quality partners. Communication is important along with attention to detail and being self-motivated.

Red Flags:
Inability to work remotely
Communication and details are important along with flexibility and being able to switch between tasks as needed.
Lack of Quality Control experience

Interview process:

Potentially a phone screen
Group interview via webex.

We invite qualified candidates to send your resume to recruiting@3keyconsulting.com.  If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.

3KC Talent Acquisition Team
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