What are the responsibilities and job description for the Senior Quality Assurance Specialist position at System One?
Job Name: Senior Quality Assurance Specialist
Location: Durham, NC
Hours/Schedule: Mon- Fri 8am- 5pm
Type: Contract
Overview
Global pharma company looking to add experienced Quality Specialist to their growing team. Candidates must bring a BS Degree, 5 years of Quality Assurance experience within pharmaceutical manufacturing, and experience with equipment and batch review qualification activities. This is not a validation or IT role.
Responsibilities:
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Location: Durham, NC
Hours/Schedule: Mon- Fri 8am- 5pm
Type: Contract
Overview
Global pharma company looking to add experienced Quality Specialist to their growing team. Candidates must bring a BS Degree, 5 years of Quality Assurance experience within pharmaceutical manufacturing, and experience with equipment and batch review qualification activities. This is not a validation or IT role.
Responsibilities:
- Reporting to the Quality Assurance Organization, will independently manage project assignments.
- 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.
- Minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent)
- 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.
- Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills.
- Must have very strong relationship building skills.
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
