Rhode Island Staffing
Quality Assurance Senior Associate
Rhode Island Staffing, West Greenwich, Rhode Island, us, 02817
Quality Assurance Specialist
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. 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 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 the 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. Pay and benefits: The pay range for this position is $25.00 - $35.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Workplace type: This is a fully onsite position in West Greenwich, RI. Application deadline: This position is anticipated to close on Oct 2, 2025. About Actalent: Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, please email actalentaccommodation@actalentservices.com for other accommodation options.
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. 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 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 the 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. Pay and benefits: The pay range for this position is $25.00 - $35.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Workplace type: This is a fully onsite position in West Greenwich, RI. Application deadline: This position is anticipated to close on Oct 2, 2025. About Actalent: Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, please email actalentaccommodation@actalentservices.com for other accommodation options.