Quality Assurance Senior Associate with GMP, Quality/Manufacturing

Aequor; West Greenwich (RI); On-site; USD 39,000 - 55,000; Full time

Job summary

Aequor in West Greenwich, RI seeks a Quality Assurance Senior Associate with GMP, Quality/Manufacturing and Documentation experience. This onsite contract role requires working on a rotating 12-hour shift, supporting manufacturing operations and real-time quality decisions with PQA on the floor.

The ideal candidate has cGMP knowledge, strong communication, and proficiency with Microsoft Office. You will review GMP documentation, batch records, and deviations, ensure data integrity, and escalate

Qualifications

• GMP experience is a must.
• Knowledge of data integrity and good documentation practices.
• Excellent written and verbal communication skills.
• Bachelor’s degree and 2 years of Quality/Manufacturing work experience.
• Experience in a cGMP environment.
• Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint, MS Teams).

Responsibilities

• Provide Quality oversight for Manufacturing operations to ensure products are manufactured, tested, stored, and distributed according to applicable regulations.
• Review and approve cGMP processes, procedures, documents and records; review logbooks, batch records, attachments, work orders, and other GMP documentation.
• Ensure deviations from established procedures are documented per procedures.
• Ensure production records and testing results are complete, accurate, and documented per written procedures and cGMP requirements.
• Alert management of quality, compliance, supply and safety risks.
• Be on the floor in clean room space for majority of shift; gowning in and out of frocks and coveralls.

Skills

GMP experience

Team collaboration

Communication skills

Data integrity knowledge

cGMP knowledge

Ambiguity navigation

Education

Bachelor’s degree

Tools

Microsoft Office

Job description

Quality Assurance Senior Associate with GMP, Quality/Manufacturing, and Documentation Experience (Onsite Job in West Greenwich, RI)

Terms: Contract W2 Only

Duration : 12 Months Contract (Will Get Extended for Long)

It’s a day shift with 12 hours per day and rotating shift.

Skill Sets:

Ideal Candidate: GMP experience is a must, Independent but able to work within a team structure, Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams), Knowledge of Good documentation practices and data integrity requirements, Excellent written and verbal communication skills.

• cGMP experience
• 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

Description:

***This position works a rotating shift schedule, Week 1: Monday, Tuesday, Friday, Saturday Week 2: Sunday, Wednesday, Thursday, ~12 hours per day 6:45 AM – 7:00 PM ***

Ideal Candidate: GMP experience is a must, 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.

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 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.

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

Preferred Qualifications:

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

Day to Day Responsibilities:

• Quality Oversight (including Purposeful Prescence on the Floor) of bulk drug substance manufacturing operations