ApTask
Quality Assurance Senior Associate
ApTask, West Greenwich, Rhode Island, us, 02817
About Client:The client is one of the world's largest independent biotechnology companies, focusing on the discovery, development, and manufacturing of innovative human therapeutics. The company's areas of expertise include oncology, hematology, cardiovascular disease, inflammation, bone health, and neuroscience.It has developed a wide range of biologic medicines, including biotechnology drugs, therapeutic antibodies, and other innovative therapies. The company collaborates with academic institutions, biotechnology partners, and other organizations to advance its research efforts.
Rate Range: $34-$35/Hr
Job Description:
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 completedPreferred Qualifications:
Bachelor's degree and 2 years of Quality/Manufacturing work experienceExperience working in a cGMP environmentExperience with decision makingExperience with analytical testing and/or general compendia testingExperience working with batch records and other GMP documentationKnowledge of data integrity requirementsProficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams)Experience collaborating within and across functional areas and demonstrated customer service focusExcellent written and verbal communication skillsAbility to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environment
Non-benefitted (other than those mandated under state or federal law).Please note that this position does not include paid time off benefits. ApTask offers subsidized insurance coverage to our employees.
About ApTask:ApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work. As an African American-owned and Veteran-certified company, ApTask offers a comprehensive suite of services, including staffing and recruitment solutions, managed services, IT consulting, and project management. With a focus on excellence, collaboration, and innovation, ApTask provides unparalleled opportunities for professional growth and development. As a member of the ApTask team, you will have the chance to connect businesses with top-tier professionals, optimize workforce performance, and drive success across diverse industries. Join us at ApTask and be part of our mission to empower organizations to thrive while fostering a diverse and inclusive work environment.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
Candidate Data Collection Disclaimer:At ApTask, we prioritize safeguarding your privacy. As part of our recruitment process, certain Personally Identifiable Information (PII) may be requested by our clients for verification and application purposes. Rest assured, we strictly adhere to confidentiality standards and comply with all relevant data protection laws. Please note that we only collect the necessary information as specified by each client and do not request sensitive details during the initial stages of recruitment.
If you have any concerns or queries about your personal information, please feel free to contact our compliance team at businessexcellence@aptask.com
Rate Range: $34-$35/Hr
Job Description:
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 completedPreferred Qualifications:
Bachelor's degree and 2 years of Quality/Manufacturing work experienceExperience working in a cGMP environmentExperience with decision makingExperience with analytical testing and/or general compendia testingExperience working with batch records and other GMP documentationKnowledge of data integrity requirementsProficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams)Experience collaborating within and across functional areas and demonstrated customer service focusExcellent written and verbal communication skillsAbility to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environment
Non-benefitted (other than those mandated under state or federal law).Please note that this position does not include paid time off benefits. ApTask offers subsidized insurance coverage to our employees.
About ApTask:ApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work. As an African American-owned and Veteran-certified company, ApTask offers a comprehensive suite of services, including staffing and recruitment solutions, managed services, IT consulting, and project management. With a focus on excellence, collaboration, and innovation, ApTask provides unparalleled opportunities for professional growth and development. As a member of the ApTask team, you will have the chance to connect businesses with top-tier professionals, optimize workforce performance, and drive success across diverse industries. Join us at ApTask and be part of our mission to empower organizations to thrive while fostering a diverse and inclusive work environment.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.
Candidate Data Collection Disclaimer:At ApTask, we prioritize safeguarding your privacy. As part of our recruitment process, certain Personally Identifiable Information (PII) may be requested by our clients for verification and application purposes. Rest assured, we strictly adhere to confidentiality standards and comply with all relevant data protection laws. Please note that we only collect the necessary information as specified by each client and do not request sensitive details during the initial stages of recruitment.
If you have any concerns or queries about your personal information, please feel free to contact our compliance team at businessexcellence@aptask.com