Quality Assurance Senior Associate NS
Actalent, West Greenwich, RI, United States
Position Overview
Quality Oversight Specialist – Night Shift (Onsite) is responsible for providing quality oversight for large molecule Bulk Drug Substances (BDS), Drug Products (DP), and Finished Products (FP) manufactured at external contract manufacturing facilities. The role ensures compliance with current Good Manufacturing Practices (cGMP) and supports manufacturing operations through documentation review, communication, and quality support. Responsibilities include translating technical documentation such as batch records, investigations, change controls, and complaint records into English and working closely with quality representatives located at contract manufacturing sites.
Key Responsibilities
Review and translate technical documents (batch records, investigations, change controls, complaints) into English.
Provide quality oversight and support to manufacturing activities in a cGMP environment.
Assist production operations with documentation and adherence to established procedures.
Communicate critical information throughout the shift and ensure effective handoff to the incoming shift.
Collaborate with internal teams and on-site quality personnel at contract manufacturing facilities.
Ensure compliance with applicable quality and documentation standards.
Required Skills & Experience
Knowledge of manufacturing processes and facility equipment.
Ability to interpret and apply cGMP principles and quality standards.
Quality assurance or manufacturing experience within the pharmaceutical or medical device industry.
Strong written and verbal communication skills.
Fluency in the required language(s), both written and spoken (as applicable).
Basic proficiency with Microsoft Word.
Strong attention to detail and ability to follow written procedures.
Team-oriented mindset and effective communication skills.
Basic Qualifications
High School Diploma/GED with 4 years of relevant work experience.
Associate’s Degree with 2 years of relevant work experience.
Bachelor’s Degree with 6 months of relevant work experience.
Master’s Degree.
Top Skills Needed
cGMP and current Good Documentation Practices (cGDP).
Clear and effective communication.
Ability to follow written procedures and Standard Operating Procedures (SOPs).
Team collaboration and reliability.
Ideal Candidate Will Demonstrate
Strong communication and teamwork skills.
Ability to follow detailed written instructions.
Willingness and availability to work night shifts and rotating schedules.
Accountability and attention to detail in a regulated environment.
Job Type & Location
This is a Contract position based out of West Greenwich, RI.
Pay And Benefits
The pay range for this position is $35.00 - $40.00/hr.
Benefits
Medical, dental & vision.
Critical Illness, Accident, and Hospital.
401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available.
Life Insurance (Voluntary Life & AD&D for the employee and dependents).
Short and long‑term disability.
Health Spending Account (HSA).
Transportation benefits.
Employee Assistance Program.
Time Off/Leave (PTO, Vacation or Sick Leave).
Workplace Type
This is a fully onsite position in West Greenwich, RI.
Application Deadline
This position is anticipated to close on May 1, 2026.
Diversity, Equity & Inclusion
Hiring diverse talent.
Maintaining an inclusive environment through persistent self‑reflection.
Building a culture of care, engagement, and recognition with clear outcomes.
Ensuring growth opportunities for our people.
Actalent is an equal opportunity employer.
#J-18808-Ljbffr
Quality Oversight Specialist – Night Shift (Onsite) is responsible for providing quality oversight for large molecule Bulk Drug Substances (BDS), Drug Products (DP), and Finished Products (FP) manufactured at external contract manufacturing facilities. The role ensures compliance with current Good Manufacturing Practices (cGMP) and supports manufacturing operations through documentation review, communication, and quality support. Responsibilities include translating technical documentation such as batch records, investigations, change controls, and complaint records into English and working closely with quality representatives located at contract manufacturing sites.
Key Responsibilities
Review and translate technical documents (batch records, investigations, change controls, complaints) into English.
Provide quality oversight and support to manufacturing activities in a cGMP environment.
Assist production operations with documentation and adherence to established procedures.
Communicate critical information throughout the shift and ensure effective handoff to the incoming shift.
Collaborate with internal teams and on-site quality personnel at contract manufacturing facilities.
Ensure compliance with applicable quality and documentation standards.
Required Skills & Experience
Knowledge of manufacturing processes and facility equipment.
Ability to interpret and apply cGMP principles and quality standards.
Quality assurance or manufacturing experience within the pharmaceutical or medical device industry.
Strong written and verbal communication skills.
Fluency in the required language(s), both written and spoken (as applicable).
Basic proficiency with Microsoft Word.
Strong attention to detail and ability to follow written procedures.
Team-oriented mindset and effective communication skills.
Basic Qualifications
High School Diploma/GED with 4 years of relevant work experience.
Associate’s Degree with 2 years of relevant work experience.
Bachelor’s Degree with 6 months of relevant work experience.
Master’s Degree.
Top Skills Needed
cGMP and current Good Documentation Practices (cGDP).
Clear and effective communication.
Ability to follow written procedures and Standard Operating Procedures (SOPs).
Team collaboration and reliability.
Ideal Candidate Will Demonstrate
Strong communication and teamwork skills.
Ability to follow detailed written instructions.
Willingness and availability to work night shifts and rotating schedules.
Accountability and attention to detail in a regulated environment.
Job Type & Location
This is a Contract position based out of West Greenwich, RI.
Pay And Benefits
The pay range for this position is $35.00 - $40.00/hr.
Benefits
Medical, dental & vision.
Critical Illness, Accident, and Hospital.
401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available.
Life Insurance (Voluntary Life & AD&D for the employee and dependents).
Short and long‑term disability.
Health Spending Account (HSA).
Transportation benefits.
Employee Assistance Program.
Time Off/Leave (PTO, Vacation or Sick Leave).
Workplace Type
This is a fully onsite position in West Greenwich, RI.
Application Deadline
This position is anticipated to close on May 1, 2026.
Diversity, Equity & Inclusion
Hiring diverse talent.
Maintaining an inclusive environment through persistent self‑reflection.
Building a culture of care, engagement, and recognition with clear outcomes.
Ensuring growth opportunities for our people.
Actalent is an equal opportunity employer.
#J-18808-Ljbffr