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Quality Assurance Manager-REMOTE (JP7746)

West Greenwich, Rhode Island · Biotech/Pharmaceutical
Job Title: Quality Assurance Manager-REMOTE (JP7746)
Location: West Greenwich, Rhode Island 02817
Employment Type: Contract
Duration: 12 months with likely extensions
Job posting date: 2 October 2020
Note: Remote
 
3 Key Consulting is hiring a Quality Assurance Manager for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
 
Job Summary:
  • INTERVIEWS: Wednesday, Thursday, Friday 10am-12pm & 3-4pm PST.
  • Candidate will be fully remote.
  • 2 positions available.
  • Open to any time zone.
  • Candidate will be managing a system validation, not individuals.
  • 5+ years of QA with emphasis of computerized system validation.
  • Must have QA experience, Compliance experience, & Computerized system validation
  • Pharma & Biotech experience must have
  • Review validation/qualification packages for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis.
  • Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations.
  • Bring critical exceptions or deviations to management’s attention and initiate and enforce necessary improvements and corrections to established systems and processes.
  • Initiate, execute, and track completion of Change Control and Non Conformance requests related to computer systems.
  • In support of clients ’s Quality Assurance program manages and oversees the operations of a specific area(s) of responsibility
 
FUNCTIONS
1. Responsible for hiring, training, supervising and performance management of staff.
2. May perform or oversee the following functions:
a) Review and approve product MPs
b) Approve process validation protocols and reports for Mfg. processes.
c) Approve Environmental Characterization reports
d) Approve planned incidents
e) Represent QA on NPI team
f) Lead investigations
g) Lead plant audits, participate in site audits
h) Approve change-over completion
g) May perform work of QA Specialist
 
EDUCATION/LICENSES
  • Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s 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 workloads.
• 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 client Values/Leadership Practices.

Preferred Qualification
Available to work in 2nd shift and non-standard shift.
 
Top Must have Skill Sets:
  • Regulatory Compliance (GxP experience)
  • Quality Assurance experience
  • Computerized system validation experience
  • Within pharma or biotech
 Day-To-Day Responsibilities:
  • Act as reviewer and approver for operational SOP’s and Work Instructions.
  • Review of operational SOP’s and Work Instructions.
  • Review and approve change controls and class I Non Conformances.
  • Initiate and own QA Non Conformances as needed.
  • Review and approve System Life Cycle Documents (i.e. test protocols) before use in production.
  • Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information: Qualitative information, Quantitative research, Trend data.
  • Forecasts, models and utilizes advanced analytical tools.
  • Anticipates and prevents potential problems.
  • May be responsible for specific programs and/or projects.
  • Independently develops solutions that are thorough, practical and consistent with functional objectives.
Employee Value Proposition:
Opportunity to join a fast-paced team
 
Red Flags:
jump from job to job
No compliance or computerized system validation
 
Interview Process:
Webex Wednesday, Thursday, Friday 10am-12pm & 3-4pm PST.
 
 
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.
 
 
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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