Position Title: Senior Quality Assurance Associate
Work Location: West Greenwich, RI 02817
Assignment Duration: 12 months (Possible Extension)
Work Schedule: Rotating shift schedule, Week 1: Monday, Tuesday, Friday, Saturday Week 2: Sunday, Wednesday, Thursday, ~12 hours per day 6:45 AM – 7:00 PM
 
Position Summary: In this vital role, will be responsible for PQA (Plant Quality Assurance) On the Floor in support of Manufacturing activities. This position requires working directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations.
 
Key Responsibilities:

• Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current applicable regulations.
• Ensure that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations.
• Performs review and approval of cGMP processes, procedures, documents and records. Review logbooks, batch records, attachments, work orders, and other GMP documentation.
• Ensure that deviations from established procedures are documented per procedures.
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Alert management of quality, compliance, supply and safety risks.
• Complete required assigned training to permit execution of required tasks.
• Responsible for being in clean room space for majority of time on shift which includes gowning in and out of frocks and coveralls.
• Communicating and collaborating with the PQA shift to ensure required tasks are completed

 
Qualification & Experience:

• Ideal Candidate: B.S. 2+ years. GMP knowledge, previous pharma experience, QA experience, good communication, and decision makings.
• Preferred Qualifications: Bachelor’s Degree & 4 year of Quality/Manufacturing experience cGMP Experience Excellent written and verbal communication skills Experience with decision making
• Basic Qualifications High school/GED + 4 years work experience or Associate + 2 years work experience or Bachelor + 6 months work experience or Masters Degree
• Top 3 Must Have Skill Sets: Quality/Manufacturing experience in Biotech/Pharma Decision making experience Accountability and proactiveness

 
Day to Day Responsibilities:

• Closing executing batch records Reviewing logbooks, area documentation from manufacturing and other support teams Provide purposeful presence for manufacturing, facilities, engineering, and other QA groups Accountable to area of oversight Follow defined procedures Provide guidance for good documentation practices to staff executing processes
• Red Flags: Out of industry No GMP experience and/or no GMP knowledge No teamwork dynamics
• Why is the Position Open: Supplement additional workload on team

 
 
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: $ 30.00/hr.