Senior Quality Assurance Associate

SPECTRAFORCE; West Greenwich (RI); In loco; USD 48.216 - 52.348; Part-time

Descrizione del lavoro

A leading biotechnology and pharmaceutical company is seeking a QA Senior Associate to provide quality oversight in a GMP environment. This role involves working on night shifts (7 PM - 7 AM) to ensure compliance with good manufacturing practices and documentation. The ideal candidate will have a background in sciences and experience in quality assurance within the biotech or pharma industry.

Competenze

• Prior experience working night shifts in a biotech or pharmaceutical GMP-regulated environment.
• Strong understanding of GMP and GDP.
• Proven ability to work nights long-term.

Mansioni

• Provide quality oversight for operations and products.
• Ensure compliance with cGMP and regulations.
• Perform review and approval of cGMP processes and documents.

Conoscenze

GMP experience

Academic background in Sciences

Quality/Compliance/Operations experience

Formazione

Bachelor’s degree + 2 years experience in QA or MFG

Associate’s degree + 6 years experience in QA or MFG

Descrizione del lavoro

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