Quality Assurance Senior Associate

Creative Solutions Services, LLC; West Greenwich (RI); On-site; USD 65,000 - 75,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Plant Quality Assurance on-the-floor role in Rhode Island. The position works a rotating 12-hour day schedule with 6:45 AM–7:00 PM shifts and zero remote work, in an onsite ARI facility.

The ideal candidate has GMP experience, strong data integrity knowledge, and excellent communication skills. You’ll support manufacturing operations, ensure cGMP compliance, and review records and batch documentation.

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 (Outlook, Word, Excel, PowerPoint, MS Teams).
• Experience collaborating across functional areas and strong customer service.

Responsibilities

• Provide Quality oversight to ensure operations, products are manufactured, tested, stored, and distributed per regulations.
• Ensure facilities, equipment, materials, organization, processes, procedures and products follow cGMP and regulations.
• Review cGMP processes, procedures, documents and records; review logbooks, batch records, attachments, work orders, and GMP docs.
• Ensure deviations from procedures are documented per procedures.
• Ensure production records and testing results are complete and correctly documented per procedures and cGMP.
• Alert management to quality, compliance, supply and safety risks.
• Complete required training for tasks.
• Be in clean room space for majority of shift with gowning in/out of frocks and coveralls.
• Collaborate with PQA shift to complete tasks.

Skills

GMP experience

Drive

Teamwork

Microsoft Office

Data integrity

Communication skills

Education

Bachelor's degree

2 years Quality/ Manufacturing experience

Tools

Microsoft Office

Job description

100% onsite ARI building 30 (No remote work)

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, drive, 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.

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

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

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