Quality Assurance Manager

Published date Posted on WorkingNomads on Jun 23, 2022 (6 d ago)
Job Title:Quality Assurance Manager, Biopharma Remote (JP10410)
Location:Thousand Oaks, CA (Remote, able to support PST/EST)
Employment Type: Contract
Business Unit:
GxP Computer Systems QA Process Support
Duration:6+ months with likely extensions
Posting Date:06/07/2022

3 Key Consulting is hiring aQuality Assurance Managerfor a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:

Remote position; EST and PST hours preferred.In support of clients Quality Assurance program manages and oversees the operations of a specific area(s) of responsibility

FUNCTIONS:
  • Responsible for hiring, training, supervising and performance management of staff.
  • May perform or oversee the following functions:
    • Review and approve product MPs
    • Approve process validation protocols and reports for Mfg. processes.
    • Approve Environmental Characterization reports
    • Approve planned incidents
    • Represent QA on NPI team
    • Lead investigations
    • Lead plant audits, participate in site audits
    • Approve change-over completion
    • May perform work of QA Specialist

EDUCATION/LICENSES
Doctorate degreeorMasters degree and 3 years of directly related experienceor
Bachelors degree and 5 years of directly related experience.
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources.


COMPETENCIES/SKILLS
  • Project management skills
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Initiate and lead cross functional teams.
  • Collaborate and communicate with higher level outside resources.
  • Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development.
  • Strong communication (both written and oral), facilitation, and presentation skills.
  • Strong skill in working independently and to effectively interact with various levels.
  • Ability to lead and influence staff outside own organization.
  • Ability to motivate staff and manage and distribute work loads.
  • Able to manage performance issues and conflict
  • Ability to provide direction and establish goals for individual staff members and work group.
  • Ability to evaluate documentation/ operations according to company and regulatory guidelines
  • Ability to interact with regulatory agencies
  • Demonstrate the company Values/Leadership Practices

Preferred Qualification
Available to work in 2nd shift and non-standard shift.

Why is the Position Open?
Supplement additional workload on team.

Top Must-Have Skill Sets:
  • Computerized System Periodic Review
  • Validation experience
  • Quality Record Management Experience (change control, deviations)
  • Supplier evaluations/ assessments (activity)
  • Strong writing skills/ concise communication

Day to Day Responsibilities:
Perform Computerized System Periodic Review, Validation, Quality Record Management (change control, deviations)
Supplier evaluations/ assessments (activity) periodic reviews

Red Flags:
  • No quality assurance experience, no regulated industry experience.
  • Candidate needs to be a self starter and seasoned in this industry (5+ years would be ideal) - Aerospace, Biotech, pharma highly preferred
  • Candidate should have strong writing skills and be able to briefly but concisely explain a project.

Employee Value Proposition:
Unique opportunity, growth, experience

Interview process:
Phone screening followed by video interview.

We invite qualified candidates to sendyour resume to
recruiting@3keyconsulting.com. Ifyou decide that youre not interested in pursuing this position, please feel free to take a look at the other positions on our websitewww.3keyconsulting.com/careers. You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.


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