Senior Associate, QA - GMP

Global-Technical-Talent-1; West Greenwich (RI); On-site; USD 32,000 - 36,000; Part time

Benefits offered by this job

Medical, Vision, and Dental Insurance

401k Retirement Fund

Job summary

GTT is seeking a Senior Associate, QA - GMP to support our West Greenwich, RI manufacturing site. You will perform PQA on the floor during bulk drug substance operations, facilitating real-time quality decisions and deviations in a fast-paced GMP environment.

Key duties include providing quality oversight of manufacturing, reviewing cGMP documents, ensuring records are complete, and alerting management to risks.

Qualifications

• GMP experience required; prior GMP industry preferred.
• Academic background in Sciences.
• Must be a team player; individual contributors not sought.
• Experience with cGMP documentation and batch records.

Responsibilities

• Provide Quality oversight for Manufacturing operations to ensure CGMP compliance.
• Review and approve cGMP processes, procedures, documents, and records.
• Ensure production records and testing results are complete and accurate.
• Alert management to quality, compliance, risks.
• Work on the floor in clean room space and gowning.

Skills

cGMP experience

Team player

Communication skills

Data integrity knowledge

Prioritization under ambiguity

Education

High school diploma / GED

Associate degree

Bachelor's degree

Master's degree

Tools

Microsoft Office (Outlook, Word, Excel, PowerPoint, MS Teams)

Job description

Senior Associate, QA - GMP

Location: West Greenwich, RI

Onsite Flexibility: Onsite

Contract Details

• 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.

Job Summary

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.

Key Responsibilities

• 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.

Required Skills

• 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

Preferred 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

Education Requirements

• 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

Required Experience

• 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.

Nice-to-Have Experience

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

Important Notes

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

Benefits

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

About GTT

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.