Genesis10
Senior Specialist Quality Assurance - Level III (Senior)
Genesis10, Durham, North Carolina, United States, 27703
Rate Range: $48-$52/Hr
Job Description
Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 2 years experience in the Pharmaceutical Industry. Would consider Associates w/good relevant experience.
Must have working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products with experience in quality assurance oversight of sterile manufacturing, sterile process validation and/or sterile process technology transfer.
Responsibilities
Preferred experience in the assessment and preparation of manufacturing sites for Pre‑Approval inspections by Regulatory agencies for new products.
Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills. Must have very strong relationship building skills.
Client‑X, Manufacturing Execution System would be a plus, familiar with SAP a plus.
These positions are more traditional Quality Assurance type stuff as the project has moved past most of the qualification stages.
Batch record review/approval.
Technical protocol review/approval.
Equipment qualification protocol review/approval.
Deviation review/approval.
Execute shop floor quality audits.
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.
Applicants may be required to attend interviews in person or by video conference. Candidates may be required to present a 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. We only collect the necessary information as specified by each client and do not request sensitive details during the initial stages.
Questions about your personal information can be directed to
businessexcellence@aptask.com .
Applicant Consent By submitting your application, you agree to ApTask's www.aptask.com Terms of Use and Privacy Policy, and provide your consent to receive SMS and voice call communications regarding employment opportunities that match your resume and qualifications. You understand that your personal information will be used solely for recruitment purposes and that you can withdraw your consent at any time by contacting us at 732‑355‑8000 or help@aptask.com. Message frequency may vary. Msg & data rates may apply.
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Job Description
Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 2 years experience in the Pharmaceutical Industry. Would consider Associates w/good relevant experience.
Must have working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products with experience in quality assurance oversight of sterile manufacturing, sterile process validation and/or sterile process technology transfer.
Responsibilities
Preferred experience in the assessment and preparation of manufacturing sites for Pre‑Approval inspections by Regulatory agencies for new products.
Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills. Must have very strong relationship building skills.
Client‑X, Manufacturing Execution System would be a plus, familiar with SAP a plus.
These positions are more traditional Quality Assurance type stuff as the project has moved past most of the qualification stages.
Batch record review/approval.
Technical protocol review/approval.
Equipment qualification protocol review/approval.
Deviation review/approval.
Execute shop floor quality audits.
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.
Applicants may be required to attend interviews in person or by video conference. Candidates may be required to present a 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. We only collect the necessary information as specified by each client and do not request sensitive details during the initial stages.
Questions about your personal information can be directed to
businessexcellence@aptask.com .
Applicant Consent By submitting your application, you agree to ApTask's www.aptask.com Terms of Use and Privacy Policy, and provide your consent to receive SMS and voice call communications regarding employment opportunities that match your resume and qualifications. You understand that your personal information will be used solely for recruitment purposes and that you can withdraw your consent at any time by contacting us at 732‑355‑8000 or help@aptask.com. Message frequency may vary. Msg & data rates may apply.
#J-18808-Ljbffr