QA CSV Specialist-Contract - (12 Months)

Company Description

Sia Partners is a next-generation management consulting firm. We offer a unique blend of AI and design capabilities, augmenting traditional consulting to deliver superior value to our clients. Counting 3,000 consultants in 19 countries, we expect to achieve $420 million in revenue for the current fiscal year. With a global footprint and expertise in more than 30 sectors and services, we optimize client projects worldwide. Through our Consulting for Good approach, we strive for next-level impact by developing innovative CSR solutions for our clients, making sustainability a lever for profitable transformation.

Job Description

Contract roles are geared toward independent professionals interested in temporary or project-based work.

Sia Title: Project Consultant (Exempt Contractor) 

Project Title: QA CSV Specialist

Level: Mid-Senior

Project Length: This is a temporary position with an expected duration of 12 months 

Project Hours: 40 hours per week

Location: West Point or Springhouse, PA

The expected compensation range for this contract position is $140,0000 to $150,000 per year. The exact pay rate will vary depending on a wide array of factors, which may include but are not limited to skills, experience, and location.

Key Responsibilities:  One of our premier clients is seeking a talented and driven individual to join our Quality Assurance Computer System Validation (CSV) 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.

• 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.
• Lead validation teams on understanding validation best practices and applying quality principles.
• Reviews various GxP deliverables for conformance with SDLC baseline criteria and other internal and external regulations.
• Identifies and resolves issues interfering with execution of deliverables. Implements practices designed to eliminate or minimize reoccurrences.
• 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.
• Perform Supplier Assessments to ensure vendor compliance to regulation and standards before introducing instruments or applications into the lab environment.
• Attend meetings as quality representative and capture meeting minutes, escalating items as appropriate.
• Oversee team’s progress and accomplishments on instrument 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

Qualifications

• B.S. and/or M.S. degree in an appropriate Life Science, Computer Science, Information Technology or Engineering discipline.
• At least 5-8 years of experience working in a Pharmaceutical/Biotechnology industry; experience working in a health authority regulated (e.g. GxP) environment.
• 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.
• Possess excellent time management skills
• High attention to detail
• Able to work autonomously / independently
• Can work through problems and can create alternate solutions
• Knows when to raise issues
• Experience with Project Management principles preferred
• Experience with PowerBI preferred
• Expertise with end-to-end data governance preferred
• Knowledge of published regulatory agency data integrity, computer software assurance guidance preferred
• Moderate level of experience with electronic tools such as software providing document management and testing capabilities preferred
• Experience using Kneet software preferred

Additional Information

At this time, Sia Partners does not intend to pursue employment with applicants who will require now or in the future visa sponsorship by our company for work authorization in the United States (i.e., H1-B visa, F-1 visa (OPT), TN visa, or any other non-immigrant status).

Project Consultant Benefits

• Statutory Time Off – Sick ​
• Medical, Dental, Vision: Eligible for Purchase Option
• 401(k) Participation: Eligible after one month of employment with matching and 100% vesting first day of participation

Our Commitment to Diversity

Diversity, equity, inclusion, and belonging (DEIB) are part of Sia Partners’ DNA. Thanks to our expertise in several sectors and our international growth, our teams include a variety of experiences and cultures. We’re confident that promoting DEIB creates an environment in which everyone can reach their full potential.

Our global network, DEIB@Sia Partners, brings together our people worldwide to facilitate local and global progress, focused on the following areas:

• Gender equality (global Gender Equality Index score of 91/100 for FY19-20)
• LGBTQ+
• Race & Ethnicity
• Working Parents
• Disabilities

Sia Partners is an equal opportunity employer. All aspects of employment, including hiring, promotion, remuneration, or discipline, are based solely on performance, competence, conduct, or business needs.

To learn more about our mission, values, and business sectors, please visit our website.

Sia Partners is an equal opportunity employer. All aspects of employment, including hiring, promotion, remuneration, or discipline, are based solely on performance, competence, conduct, or business needs.