Position Details:

Job Title: Quality Assurance Senior Associate

Location: West Greenwich, RI Onsite

Duration: 12 Months contract with possibility of extension

Job Summary

1 EW needed for Rotating night shift (C shift)

7 PM – 7 AM ET (12 hour day)

Five (5) working days in one week and two (2) working days the following week

Notes from Hiring Manager Intake:

· What location will this role be tied to? 100% ONSITE in Client's Rhode Island (USRI) location/ No Remote Work.

· What is the working environment for this role?

· IE office based, lab based, manufacturing floor? This is plant quality assurance role, therefore the EW will spend 50-60% of their time in a QA role on the manufacturing floor and the remaining time the EW will be office based.

· What type of qualities/characteristics are you looking for in candidates to work best with your team? Previous bio pharma experience, clean room behavior experience, the team needs someone who can work in a fast paced/agile environment. EW will need to be comfortable managing change.

· What is your minimum education and work experience requirements you think it suitable for this role? B.S. 2+ years. GMP knowledge, previous pharma experience, QA experience, good communication, and decision making.

Job Details:

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.

Responsibilities Include the Following:

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