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Quality Assurance Senior Associate (JP8367)

Woburn, Massachusetts · Biotech/Pharmaceutical
Job Title: Quality Assurance Senior Associate (JP8367)
Location: Woburn Massachusetts 01801
Employment Type: Contract
Duration: 12 months with likely extensions
Job posting date: 3.12.2021.
Note: Onsite Essential
Option of Two shifts:  first shift (7am-3pm) OR second shift (3pm-11pm). Please indicate on top of resume which shift candidate is open to.
3 Key Consulting is hiring a Quality Assurance Senior Associate for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Job Summary:
  • Bachelors, 4+ years/ Associates 6+ years: Quality, Manufacturing, Validation, Process Development or Process Engineering experience (PHARMA OR BIOTECH)
  • The Senior Associate Quality Assurance will be accountable for Quality On-the-Floor in support of Manufacturing activities.
  • This position provides the opportunity to work directly with Manufacturing staff during operations to facilitate real-time decision-making regarding quality requirements and deviations.
  • This is a unique opportunity to foster a positive relationship and learning environment between Manufacturing and Quality staff.
  • The client’s Quality Assurance On-the-Floor provides mentoring, guidance and direction to Manufacturing, Quality Control and Facilities & Engineering staff in regard to compliance and quality systems.

  • Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies
    Bachelor’s degree and 2 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience, OR
  • Associate’s degree and 6 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience, OR
  • High school diploma / GED and 8 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience.
  • Previous QA oversight of manufacturing, analytical and engineering activities.
Top Must have Skill Sets:
  • Responsible for providing Quality oversight to ensure that operations for licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations.
  • Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
  • Performs review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to deviations, CAPAs, and validations.
Day-To-Day Responsibilities:
  • Supports Continual Improvement initiatives, programs and projects.
  • Ensures that changes that could potentially impact product quality are assessed according to procedures.
  • Ensures that deviations from established procedures are investigated and documented per procedures.
  • Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
  • Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures.
  • Alerts senior management of quality, compliance, supply and safety risks.
  • Represents the quality unit during audits and inspections as needed.
  • Supports internal/external audits and inspections as part of the audit/inspection management team as needed.
  • Completes required assigned training to permit execution of required tasks.

Preferred Qualifications
  • Organizational skills, including ability to follow assignments through to completion.
  • Skills in leading, influencing and negotiating.
  • Knowledge in area of expertise
  • Collaborate and coordinate with higher level outside resources.
  • Knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
  • Ability to interact with regulatory agencies.
  • Word processing, presentation, database and spreadsheet application skills
  • Communication (both written and oral), facilitation and presentation skills
  • Skill in working independently and to effectively interact with various levels.
  • Basic data trending and evaluation
  • Ability to evaluate compliance issues.
Employee Value Proposition:
Ability to be a part of the cleint’s Mission and Values
Red Flags:
Jumpy job history, lack of: Quality, Manufacturing, Validation, Process Development or Process Engineering experience
Interview Process:
WebEx interviews
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.
3KC Talent Acquisition Team

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