Senior Quality Assurance Associate

Planet Pharma; West Greenwich (RI); On-site; USD 26,000 - 37,000; Full time

Job summary

Planet Pharma is seeking a Plant Quality Assurance on-the-floor role to support manufacturing operations. You will interact with manufacturing staff to facilitate real-time quality decisions during bulk drug substance operations. The role focuses on ensuring operations follow cGMP, reviewing batch records and logs, and communicating risks to management.

Clean room duties and training are required. Applicants should have a Bachelor's degree and at least 2 years of quality/manufacturing

Qualifications

• Bachelor's degree in a relevant field and 2 years of Quality/Manufacturing work experience.
• Experience in a cGMP environment with batch records and GMP documentation.
• Strong written and verbal communication, with ability to work across functions.

Responsibilities

• Provide Quality oversight to ensure operations products are manufactured, tested, stored, and distributed according to regulations.
• Ensure facilities, equipment, materials, organization, processes, procedures, and products follow cGMP practices.
• Review cGMP processes, procedures, documents and records; including logbooks and batch records.
• Document deviations per procedures and ensure production records are complete and accurate.
• Alert management of quality, compliance, supply and safety risks.
• Complete required training to permit execution of tasks.
• Work in clean room space; gowning in/out of frocks and coveralls.
• Collaborate with PQA shift to ensure tasks are completed.

Skills

Quality oversight

Decision making

Analytical testing

Batch records

Data integrity

Communication skills

cGMP experience

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Target PR Range: 19-27/hr DOE

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:

• Bachelors 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