Quality Assurance Senior Associate
Spectraforce
West Greenwich, Rhode Island
a month ago
Job Description
Job Title: Quality Assurance Senior Associate
Location: West Greenwich, RI
Duration: 10+ months
Description:
NIGHT SHIFT ADD 15% DIFFERNTIAL
ONSITE 100% - QA Sr. Associate (Nights)- No remote work
12-hour night shifts (7:00 PM - 7:00 AM) on a rotating schedule.
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. Familiar with GxPs, industry practices and basis regulations.
2. Has worked in Biotech/ Pharma industry.
3. Academic background in Sciences
Day to Day Responsibilities:
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, perform housekeeping walkthroughs, provide quality oversight, support real-time decision-making regarding quality incidents.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
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: $30.56/hr.
Location: West Greenwich, RI
Duration: 10+ months
Description:
NIGHT SHIFT ADD 15% DIFFERNTIAL
ONSITE 100% - QA Sr. Associate (Nights)- No remote work
12-hour night shifts (7:00 PM - 7:00 AM) on a rotating schedule.
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. Familiar with GxPs, industry practices and basis regulations.
2. Has worked in Biotech/ Pharma industry.
3. Academic background in Sciences
Day to Day Responsibilities:
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, perform housekeeping walkthroughs, provide quality oversight, support real-time decision-making regarding quality incidents.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
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: $30.56/hr.