Job Title: Quality Assurance Senior Associate
Location: West Greenwich, RI, 02817
Duration: 13+ months (Possible extension)
 
ONSITE 100% - (Nights)- No remote work
12-hour night shifts (7:00 PM - 7:00 AM) on a rotating schedule.
NIGHT SHIFT ADD 15% DIFFERNTIAL.
Description:
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-the-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, 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. This position works a rotating night shift (C shift), with five day working during one week (M, Tu, F, Sa, Su) and two days the following week (W, Th), shift hours are 7pm to 7am, with adaptability as required based on the business needs, provides coaching, guidance and direction to Manufacturing and Facilities & Engineering staff in regards to compliance and quality systems.

***Intake Notes:***
· How is the shift schedule decided upon each week? Is there a rotation or a set schedule for EW’s?
Schedule is pre-determined for entire year, aligning with MFG schedule. It’s rotating, yes, see above response for days/timing. EW will be following C shift rotation, 7 days across two weeks, 12 hr shift each night.

· What type of qualities/characteristics are you looking for in candidates to work best with your team?
· Team player, and good communicator. Willing to support additional workload by checking with team members, good communication with the team members on a daily basis of what needs to be prioritized and what has been completed, and understanding of when to escalate events to me.

· When reviewing resumes, what stands out to you when looking for the right applicants?
· Academic background in Sciences, and experience working in Quality Assurance or Manufacturing in either Biotech or Pharmaceutical industry.

· What is your minimum education and experience requirements as well as the maximum education/experience requirement you think it suitable for this role?
· Master’s degree OR Bachelor’s degree and 2 years of experience (in QA or MFG) OR Associate’s degree and 6 years of experience (in QA or MFG).

· What are your non negotiables for candidates?
· Experience in Biotech or Pharmaceutical industry.

· 2 Qualities of your ideal candidate?
· Has worked in similar drug manufacturing organization, within Quality or MFG for at least 2 years,
· Has Academic background in any Sciences discipline.
Top 3 Must Have Skill Sets:
1. Experience working in GMP environment, in Pharmaceutical/ Biotechnology industry.
2. Academic background in Sciences.
3. Experience working in Quality/ Compliance/ Operations.
Day to Day Responsibilities:

• Responsible for providing Quality oversight to ensure that operations 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 practices and other applicable regulations.
• Performs review and approval of cGMP processes, procedures, documents, and records, including but not limited to Standard Operating Procedures (SOPs), Batch Records, and Deviations.
• Author/review/approve quality documents, such as: SOPs, risk assessments, training materials, engineering documents, automation documents, protocols/reports.
• Provide guidance during on-the-floor analytical testing.
• Ensure that changes that could potentially impact product quality are assessed according to procedures.
• Ensure that deviations from established procedures are investigated and documented per procedures.
• Review executed batch records, attachments, and area logbooks.
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Alerts senior management of quality, compliance, supply, and safety risks.
• Completes required assigned training to permit execution of required tasks.
• Drive operational improvement initiatives, programs, and projects.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 35.20/hr.