Senior Associate, QA - GMP

Location: West Greenwich, RI

Onsite Flexibility: Onsite

• Position Type: Contract
• Contract Duration: 13 months
• Pay Rate: $23.00–$26.00 / Hour (USD)
• Shift /
  
  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
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

In this vital role, you 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.

• Provide Quality oversight for Manufacturing operations to ensure that 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.
• Perform 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 to 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.

Day to Day Responsibilities:

• Quality Oversight (including Purposeful Presence on the Floor) of bulk drug substance manufacturing operations.
• GMP documentation review/approval (including EURs, electronic logbooks, RT reports, Work Orders, batch records, etc.).
• Interim and reject cage management.

• cGMP experience (must have)
• Experience collaborating within and across functional areas and demonstrated customer service focus
• Ability to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environment
• Independent but able to work within a team structure
• Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams)
• Knowledge of data integrity requirements
• Excellent written and verbal communication skills

• Experience working in a cGMP environment
• Experience with decision-making
• Experience with analytical testing and/or general compendia testing
• Experience working with batch records and other GMP documentation
• Knowledge of data integrity requirements
• Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams)
• Experience collaborating within and across functional areas and demonstrated customer service focus
• Excellent written and verbal communication skills
• Ability to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environment

• High school diploma / GED and 4 years of work experience, OR
• Associate degree and 2 years of work experience, OR
• Bachelor's degree and 6 months of work experience, OR
• Master's degree

• GMP experience is required; no previous experience working in a GMP-regulated industry is a disqualifier.
• Academic background in Sciences is expected.
• Must be a team player; individual contributors not sought.

• Bachelor's degree and 2 years of Quality/Manufacturing work experience

• Interview Process:
  Video conference — 1 interview with the hiring manager.

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.