Title: Quality Assurance Senior Associate Location: West Greenwich, RI 02817 Duration: 12 Months (Possibility of extension) Schedule: 100% Onsite - Night shift starts 6:45 pm, Standard 12 hours rotation
Job Overview We are seeking a detail-oriented professional responsible for quality oversight activities related to Large Molecule manufacturing, including Bulk Drug Substances (BDS), Drug Products (DP), and Finished Products (FP) at contract manufacturing sites supporting us. This role involves reviewing and translating technical documentation into English, ensuring compliance with cGMP standards, and collaborating closely with on-site quality teams.
Must-Have Skills (Top 3):
Strong understanding of cGMP / Good Documentation Practices
Excellent communication skills (written & verbal)
Ability to follow written procedures (SOPs) strictly
Red Flags (Disqualifiers)
Poor communication skills
Inability to work in a team environment
Failure to follow written procedures
Unwillingness to work night shifts / rotational schedule
Key Responsibilities
Perform quality oversight functions for BDS, DP, and FP manufacturing
Review and translate:
Batch records
Investigations
Change controls
Complaint documentation
Ensure compliance with cGMP and Good Documentation Practices
Assist production teams in maintaining quality standards
Interpret and apply Standard Operating Procedures (SOPs)
Communicate effectively with:
Internal quality teams
Contract manufacturing site personnel
Provide shift handover updates to incoming team members
Additional Required Skills:
Knowledge of process and facility equipment
Experience in pharmaceutical, biotech, or medical device industry
Basic proficiency in Microsoft Word
Strong teamwork and collaboration skills
Ability to interpret technical documentation
Fluency in required language (written & spoken)
Basic Qualifications
High School Diploma / GED + 4 years of experience, OR
Associate Degree + 2 years of experience, OR
Bachelor’s Degree + 6 months of experience, OR
Master’s Degree
Day-to-Day Responsibilities
Review and verify documentation for accuracy and compliance
Support production activities under cGMP guidelines
Follow established procedures and SOPs
Maintain continuous communication during shift
Ensure smooth handover between shifts
Applicant Notices & Disclaimers
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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: $ 37.00/hr.
