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Senior Quality Assurance AssociateSPECTRAFORCE • West Greenwich, Rhode Island, United States
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Senior Quality Assurance Associate

SPECTRAFORCE
  • US
    West Greenwich, Rhode Island, United States
  • US
    West Greenwich, Rhode Island, United States
Jetzt Bewerben

Über

Base pay range $35.00/hr - $38.00/hr
Work Setup: ONSITE 100% (N Bites) – No remote work
Shift: 12-hour night shifts ( 7:00 PM - 7:00 AM ) on a rotating schedule
Candidates who have previously worked a night shift schedule would be nice to have.
The ideal candidate is someone with prior experience working night shifts in a biotech or pharmaceutical GMP-regulated environment and is fully comfortable with the rotating 12‑hour schedule (7:00 PM - 7:00 AM) . They should have a strong understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) to efficiently review batch records, logbooks, and on‑floor QA processes .
While a scientific academic background (e.g., chemistry, biotechnology) is preferred, hands‑on industry experience can compensate for the lack of a degree. The candidate must be a strong communicator and a team player , capable of working cross‑functionally with both the QA and manufacturing teams while effectively documenting and relaying information during shift handovers.
Given the challenges past hires have faced in adjusting to the night schedule, a proven ability to work nights long‑term is critical to ensure continuity in this role.
QA Senior Associate will be responsible for Quality On the Floor in support of Manufacturing activities . This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate batch record and attachment reviews, logbook reviews, area changeover reviews , and real‑time decision‑making regarding quality incidents .
This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff .
Schedule: Rotating night shift ( C shift ) with
Week 1: 5 days (Mon, Tue, Fri, Sat, Sun)
Week 2: 2 days (Wed, Thu)
Shift hours: 7 PM to 7 AM, with flexibility as required based on business needs.
Provides coaching, guidance, and direction to Manufacturing and Facilities & Engineering staff regarding compliance and quality systems .
Intake Notes
How is the shift schedule decided upon each week?
Schedule is pre‑determined for the entire year , aligning with MFG schedule . It’s rotating (C shift rotation, 7 days across two weeks, 12‑hour shift each night).
Team player and good communicator
Willing to support additional workload by checking with team members
Communicates daily priorities and completions
Understands when to escalate events to management
What stands out in resumes:
Academic background in Sciences
Experience in Quality Assurance or Manufacturing in Biotech or Pharmaceutical industry
Minimum/Maximum education & experience requirements:
Bachelor’s degree + 2 years of experience (QA or MFG) OR
Associate’s degree + 6 years of experience (QA or MFG)
Experience in Biotech or Pharmaceutical industry
Worked in similar drug manufacturing organization within Quality or Manufacturing for at least 2 years
Academic background in any Sciences discipline
Top 3 Must Have Skill Sets
Experience working in GMP environment in Pharmaceutical/Biotechnology industry
Academic background in Sciences
Experience working in Quality/Compliance/Operations
Responsibilities
Provide Quality oversight to ensure operations and products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) , Good Documentation Practices (GDP) , and other applicable regulations
Ensure that facilities, equipment, materials, organization, processes, procedures, and products comply with cGMP and regulations
Perform review and approval of cGMP processes, procedures, documents, and records (SOPs, Batch Records, Deviations)
Author/review/approve quality documents such as SOPs, risk assessments, training materials, engineering and automation documents, protocols/reports
Ensure changes that could impact product quality are properly assessed
Ensure deviations are investigated and documented per procedures
Review executed batch records, attachments, and area logbooks
Ensure production records and testing results are complete, accurate, and compliant with procedures and cGMP requirements
Alert senior management of quality, compliance, supply, and safety risks
Complete required training to perform assigned tasks
Drive operational improvement initiatives, programs, and projects
Seniority level Associate
Employment type Contract
Job function Quality Assurance
Industries Pharmaceutical Manufacturing and Biotechnology Research
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  • West Greenwich, Rhode Island, United States

Sprachkenntnisse

  • English
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