Overview
Seeking a talented and driven individual to join our Quality Assurance Facilities and Validation team, for the launch of a new facility at West Point, PA. The candidate will play a pivotal part in ensuring the compliance and efficiency of computerized systems within the new facility, contributing to the successful implementation of our operations. This role presents an exciting opportunity to be part of a dynamic team and make a significant impact on the quality and reliability of our systems in a cutting-edge environment.
Responsibilities
Responsible for providing quality assurance support and oversight for System Development Life Cycle (SDLC) deliverables of primarily Laboratory Instrument Systems and secondary for Application Systems support GxP operations
Collaborate with cross-functional team to define risk-based approaches for computer system validation activities and testing.
Reviews various GxP deliverables for conformance with SDLC baseline criteria and other internal and external regulations.
Enforces Good Documentation Practices and ensures that SDLC deliverables are properly catalogued and available for internal and external regulatory inspection.
Provide additional support with SDLC deliverables for Enterprise Application support, as applicable.
Attend meetings as quality representative, escalating items as appropriate.
Supports team’s progress and accomplishments on validation activities ensuring project remains on target for key milestones.
Position requires individual to be on-site (West Point, PA or Springhouse, PA) an average of 4 days/week; dependent on operations
Position Qualifications
B.S. and/or M.S. degree in an appropriate Life Science, Computer Science, Information Technology or Engineering discipline.
Required Experience And Skills
At least 5-8 years of experience working in a Pharmaceutical/Biotechnology industry; experience working in a health authority regulated (e.g. GxP) environment.
Experience with laboratory instrumentation, including but not limited to: chromatography systems, mass spectrometry, spectroscopy, particle counters, osmometry, dissolution testing, and general laboratory equipment.
Industry experience including computer system validation, System Life Cycle (SLC), software validation, and/or Quality Assurance functions.
High level of expertise and exposure with agency regulations, such as 21 CFR Part 11, Part 58, Part 210, Part 211 from the US Food and Drug Administration.
High level of expertise in SLC methodology (e.g., V-model, waterfall, agile, spiral) including change management.
Extensive experience providing oversight for adherence to enterprise SLC and procedures.
Experience in creation, execution, and reviewing a change control document.
Proficient skills dealing with and understanding typical laboratory facilities and equipment.
Ability to prioritize and manage multiple initiatives, projects concurrently.
Excellent interpersonal skills including ability to work as a team member in a collaborative environment.
Excellent written and communication skills including thorough knowledge of Good Documentation Practices.
High attention to detail
Able to work autonomously / independently
Can work through problems and can create alternate solutions
Knows when to raise issues
Preferred Experience And Skills
Experience with Project Management principles
Experience with PowerBI
Expertise with end-to-end data governance
Knowledge of published regulatory agency data integrity, computer software assurance guidance.
Moderate level of experience with electronic tools such as software providing document management and testing capabilities.
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Responsibilities
Responsible for providing quality assurance support and oversight for System Development Life Cycle (SDLC) deliverables of primarily Laboratory Instrument Systems and secondary for Application Systems support GxP operations
Collaborate with cross-functional team to define risk-based approaches for computer system validation activities and testing.
Reviews various GxP deliverables for conformance with SDLC baseline criteria and other internal and external regulations.
Enforces Good Documentation Practices and ensures that SDLC deliverables are properly catalogued and available for internal and external regulatory inspection.
Provide additional support with SDLC deliverables for Enterprise Application support, as applicable.
Attend meetings as quality representative, escalating items as appropriate.
Supports team’s progress and accomplishments on validation activities ensuring project remains on target for key milestones.
Position requires individual to be on-site (West Point, PA or Springhouse, PA) an average of 4 days/week; dependent on operations
Position Qualifications
B.S. and/or M.S. degree in an appropriate Life Science, Computer Science, Information Technology or Engineering discipline.
Required Experience And Skills
At least 5-8 years of experience working in a Pharmaceutical/Biotechnology industry; experience working in a health authority regulated (e.g. GxP) environment.
Experience with laboratory instrumentation, including but not limited to: chromatography systems, mass spectrometry, spectroscopy, particle counters, osmometry, dissolution testing, and general laboratory equipment.
Industry experience including computer system validation, System Life Cycle (SLC), software validation, and/or Quality Assurance functions.
High level of expertise and exposure with agency regulations, such as 21 CFR Part 11, Part 58, Part 210, Part 211 from the US Food and Drug Administration.
High level of expertise in SLC methodology (e.g., V-model, waterfall, agile, spiral) including change management.
Extensive experience providing oversight for adherence to enterprise SLC and procedures.
Experience in creation, execution, and reviewing a change control document.
Proficient skills dealing with and understanding typical laboratory facilities and equipment.
Ability to prioritize and manage multiple initiatives, projects concurrently.
Excellent interpersonal skills including ability to work as a team member in a collaborative environment.
Excellent written and communication skills including thorough knowledge of Good Documentation Practices.
High attention to detail
Able to work autonomously / independently
Can work through problems and can create alternate solutions
Knows when to raise issues
Preferred Experience And Skills
Experience with Project Management principles
Experience with PowerBI
Expertise with end-to-end data governance
Knowledge of published regulatory agency data integrity, computer software assurance guidance.
Moderate level of experience with electronic tools such as software providing document management and testing capabilities.
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