Épargne réglementée
Consulting
QA CSV/CQV Specialist-Contract-(12 Months Plus)
Wall Street 48, 10043 New York, États-Unis
Description de l'entreprise
Sia is a next-generation, global management consulting group. Founded in 1999, we were born digital. Today our strategy and management capabilities are augmented by data science, enhanced by creativity and driven by responsibility. We’re optimists for change and we help clients initiate, navigate and benefit from transformation. We believe optimism is a force multiplier, helping clients to mitigate downside and maximize opportunity. With expertise across a broad range of sectors and services, our 3,000 consultants serve clients worldwide from 48 locations in 19 countries. Our expertise delivers results. Our optimism transforms outcomes.
Description du poste
Contract roles are geared toward independent professionals interested in temporary or project-based work.
Sia Title: Project Consultant (Exempt Contractor)
Project Title: QA CSV/CQV Specialist
Level: Mid-Senior
Project Length: This is a temporary position with an expected duration of 12 months
Project Hours:40 hours/week
Location: Onsite in Rahway NJ – Local personnel only
The expected compensation for this contract is $95 to $115 per hour. 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 their Quality Assurance Computer System Validation (CSV) team, for the launch of a new building at Rahway NJ site. 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 commissioning/qualification of the facilities, equipment and instruments in the manufacturing facility and the associated laboratories.
- Responsible for providing quality oversight for automation systems for new facilities and upgrades to the existing facilities. Automation systems include systems such as Delta V, BAS, BMS & SCADA.
- Responsible for quality oversight cleaning and thermal validation.
- Responsible for the review and approval of SOPs.
- Provide Quality support for Environmental Area and Utility Performance Qualification Plans, Protocols and Reports.
- Quality ownership for new capital projects which can include new facility associated utilities and equipment.
- Leading routine process support and improvement activities.
- Providing Quality guidance for daily production support, projects, deviations, and changes.
Compétences
Education Minimum Requirement:
- 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 10-15 years of experience working in a Pharmaceutical/Biotechnology industry experience working in a health authority regulated (e.g. GxP) environment.
- Industry experiences 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.
- Experience in creation, execution, and reviewing change control document.
- Strong interpersonal and written/oral communication skills.
- Ability to quickly process complex information and often make critical decisions with limited information.
- Proficient in applying process excellence tools and methodologies
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
- Good written and verbal communication skills are required.
- Ability to work with others in a team environment.
- Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, CQV protocols.
- Experience with TrackWise, CMMS and Maximo
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)
- Experience working in an aseptic manufacturing facility, quality testing facility, quality assurance, or manufacturing compliance.
- Demonstrated ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CQV program.
Preferred Experience and Skills:
- Experience with Project Management principles
- Expertise with end-to-end data governance
- Knowledge of published regulatory agency data integrity, computer software assurance guidance.
Informations complémentaires
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
Diversity, Equity, Inclusion & Belonging
At Sia, we believe in fostering a diverse, equitable and inclusive culture where our employees and partners are valued and thrive in a sense of belonging. We are committed to recruiting and developing a diverse network of employees and investing in their growth by providing unique opportunities for professional and cultural immersion. Our commitment toward inclusion motivates dynamic collaboration with our clients, building trust by creating an inclusive environment of curiosity and learning which affects lasting impact. Please visit our website for more information.
Sia is an equal opportunity employer. All aspects of employment, including hiring, promotion,
To learn more about our mission, values, and business sectors, please visit our website.
Sia 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.