QA Specialist

Responsible for assisting Technology & Data Quality Assurance in overseeing the Computerized Systems Validation Program

Responsible for representing Technology & Data Quality Assurance on Information Systems Compliance program related continuous process improvement initiatives.

Provides guidance to drive consistent GxP and Electronic Records / Electronic Signatures regulations compliance and validation approaches across projects to ensure compliance with regulations, and Company policies and procedures.

Responsible for reviewing and approving Computer System Validation documents to ensure compliance with written policies and procedures.

Schedules and performs assigned computerized systems audits related to the purchase or use of software.

Supports new technology initiatives as the company continually invests in new technology solutions, related processes, and computerized systems.

Essential Job Responsibilities:

Integral QA representative in numerous IT project teams. Participates in working teams to provide direction regarding quality, validation, and compliance.

Performs and coordinates the review and approval of validation deliverables including, but not limited to, computer system requirements, validation plans, test protocols, traceability matrices, executed testing documentation, and validation reports.

Work with IT staff to resolve issues identified during document reviews.

Assures compliance with corporate policies, SOPs, and regulatory agency standards (US, EU, and Japan, as needed). Identifies compliance issues and works with CSV QA staff to identify and implement corrective action as required.

Communicates compliance issues to TDQA Management.

Conducts and coordinates compliance and quality training to peers, other departments, and external customers as assigned.

Schedules and performs assigned software vendor audits of newly identified or current, regulated and business critical software vendors. Plan, conduct, and report results of assigned audits.

Assist with good manufacturing practice (GMP), good clinical practice (GCP), or good laboratory practice (GLP) audits of manufacturing sites, laboratories, investigational research centers, software providers, and related functions, as needed. Assess the adequacy and compliance of computer system development, testing, validation, and management procedures and documentation at these facilities/sites.

Effectively and accurately document audit findings in audit reports and obtain responses in a timely fashion.

Assist in the evaluation of audit responses for compliance with applicable guidelines, regulations, and company policies. Obtain remediation when responses are unacceptable.

Required Qualifications:

Identify the levels of knowledge, skills, abilities, experience and education required for the position

Minimum B.A. / B.S. with at least 5 - 7 years in Quality Assurance position within pharmaceutical environment or healthcare field.

Experience in IT Compliance roles will be considered.

Must have Computer System Validation (CSV) experience. Computer System Validation Quality Assurance / Software Quality Assurance experience desirable.

Must understand global regulatory requirements for electronic records and electronic signatures including but not limited to: US CFR 21 Part 11, EU Annex 11, EU Directive 1999/93/EC, and Japan PFSB Notification No. 0401022. Must understand associated regulatory guidance documents.

Must understand computer systems validation process, and process controls in the areas of GAMP 4 / GAMP 5, ISO 9000, ITIL, IEEE, and ASQ standards.

GxP computerized auditing experience required; Pharma, GMP, GCP, and GLP auditing experience desirable. Ability to represent the company to external stakeholders during vendor audits required.

Effective written and oral communication and interpersonal skills, facilitation, and influencing skills with an ability to develop and maintain effective relationships across Company groups and external stakeholders.

Must be capable of managing self and project teams across multiple assigned projects.