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Senior QA Specialist

1 month ago

Rensselaer, United States RCM Life Sciences and IT Full time
Contract / Right to Hire:

Title: Senior QA Specialist
Compensation: Up to $70 Per Hour, Commensurates with experience.
Location: Rensselaer, NY
Length of Contract: 1 Year

Position Description:
The Senior QA Specialist will serve as SME by supporting investigations, risk assessments, and IT Operations while verifying that GxP computerized systems operate as expected post-validation.

Responsibilities:
  • Ensure IT processes and procedures meet Quality System requirements.
  • Participate and support the Quality Risk Management (QRM) principles in the formal and informal risk assessment initiatives.
  • Provides support and guidance with quality system records activities such as change controls, corrective and prevention action plans (CAPAs), risk assessments, data integrity initiatives, deviations, internal and external audits, standard operating procedure (SOPs), work instructions/job aids, policies, etc.
  • Provide ongoing support to the Quality Auditing function with respect to IT vendors and audits.
  • Support the development, review and approval of Quality Assurance Agreements (QAA), along with the Approved Supplier List (ASL) process.
  • Collaborate with other functional areas to collect information and provide guidance through all stages of the quality management system and improvement projects
  • Ensures new systems/processes/procedures are compliant with SOPs, WIs and data and regulatory guidelines for IT and Software validation proces
  • ssist in resolution of inspection management concerns as it relates to software applications process, procedures, and data integrity
Qualifications:
  • 7+ years of experience in IT, Computer Science, Engineering, or Chemistry in an FDA regulated manufacturing environment.
  • Thorough understanding of IT CSV and QA IT roles and responsibilities in support of GxP compliance is required
  • Experience working in an FDA regulated environment with a strong emphasis on a risk-based approach to validation/qualification
  • Strong knowledge of FDA CFRs, Eudralex, and other biotech/pharma industry regulations (pertaining to IT, laboratory systems, automation, and manufacturing)
  • Strong knowledge of Data Integrity, System Development Life Cycle (SDLC) validation methodology and Software Quality requirements.
  • Understanding of root cause analysis and risk management techniques.
  • Experience with quality management systems including change control, incident management, and deviation management
  • Strong Project Management experience leading efforts requiring coordination between cross functional teams within at least one area of systems validation - e.g., laboratory equipment, facilities, utilities, manufacturing equipment, information systems, etc.
Education & Certifications:
  • Bachelor's degree in a relevant field (e.g., Life Science, Computer Science, Engineering, Information Technology) preferred.

Equal Opportunity Statement:
RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Pay Transparency:
RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices.

Disclaimer:
This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

bout RCM:
RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.