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... Specialist Senior Warranty Financial Supervisor when compiling information for legal issues involving labor and parts reimbursement disputes. * Support analysis work within section for projects; find ...
Woodcliff Lake, NJ · Hybrid
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... Specialist Senior Warranty Financial Supervisor when compiling information for legal issues involving labor and parts reimbursement disputes. * Support analysis work within section for projects; find ...
Title: Senior Specialist Quality Assurance - Level III
Location : 5325 Old Oxford Road, Durham, NC 27712
Pay Rate: $56/HR on W2
Qualifications:
Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 5 years experience in the Pharmaceutical Industry.
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.
Must have 3 years of experience with development, review, and approval of User Requirement (URS), FAT, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for pharmaceutical and biotechnology manufacturing equipment, facilities and utilities.
Responsibilities:
Preferred experience in the assessment and preparation of manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products.
• Reporting to the Quality Assurance Organization, will independently manage project assignments.
• Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills. Must have very strong relationship building skills.
• Immediate project support on review and approval of commissioning and qualification (C&Q) documents to support project delivery.
• Provide QA support including critical / constructive review and approval of GMP documentation such as Quality Agreements, Quality Risk Assessments, URS, FAT, IQ, OQ, PQ, other technical documents, change management, and manufacturing/batch documents to meet schedule milestones.
• Ensure all aspects of the project proceed in compliance with cGMP, regulations, and our Company's Quality Management System.
• Focusing on areas such as Qualification and Compliance covering Manufacturing Equipment (isolator, restricted access barrier, incubator, washer, autoclave, formulation vessel, lyophilizer, etc.).
• Review and approval of master batch records, executed records, technical protocols, investigations, change controls, SOPs, validation protocols, technical reports.
• Consults on an as-needed basis with next level manager on more complex decisions.
Must Have:
1.Manage multiple equipment docs… pre reviews, post reviews, etc.
2.Helping finish qualifications steps for equipment. Quality assurance review/approval of operations team. Existing vaccine being produced at aged facility so new facility currently in qualifications phase.
3-Top 3 skillset...attention to detail, experience with qualification of equipment, ability to collaborate/communicate effectively w/team.
4-End to end so different equipment - cell expansion, incubators, isolator, filler, lyoff, capped, inspect/automated
Kindly share your resume with answers:
Q1: how many years of exp Quality Assurance in the Pharmaceutical Industry.
Q2: How many years of exp in A: User Requirement (URS), FAT, Installation B-Qualification (IQ), C-Operational Qualification (OQ), D-Performance Qualification (PQ) for pharmaceutical and biotechnology manu
Q3: How many year of exp in cell expansion, incubators, isolator, filler, lyoff, capped, inspect/automated
Q4: how far you live and how will you commute to 5325 Old Oxford Road, Durham, NC 27712
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11 - 50 Employees
Sugar Land, TX, US