QA Computer System Validation Supervisor

• This QA Computer System Validation Supervisor provides guidance to company Supply Chain Solutions (SCS) Information Technology (IT) department to maintain validation of warehouse or support systems utilized for healthcare applications.
• This role assesses systems being evaluated for use in healthcare applications, provides training and subject matter expertise to achieve/maintain validated status.
• The incumbent identifies systems requiring validation, escalates validation issues appropriately, and provides validation expertise.
• This position manages validation documents, determines applicable regulations, and reviews and approves testing of changes to validated systems.
• The incumbent consults with internal groups (e.g., Operations, Business Development, IT, etc.) investigates and resolves healthcare issues to ensure compliance with rules and regulations.
• This position writes and revises Standard Operating Procedures (SOPs) and work instructions to ensure proper procedures are followed by Operations, IT or Order-to-Cash personnel.
• This role participates in information gathering and scheduling to prepare for internal and client audits.
• The incumbent assesses current SCS capabilities to determine SCS's ability to meet client requirements and proposed solutions.
• This position develops and revises change control procedures, training, and audits to ensure the maintenance of validation.

• Writes, executes, and reviews validation protocols, generates validation reports, and performs corrective actions for deviations to provide subject matter expertise for SCS in validation matters
• Reviews policies, procedures, and regulations with internal/external clients to determine specialized requirements and ensure compliance
• Coordinates document and data control (e.g., numbering, version control, controlled copies, etc.) to ensure documentation and data are maintained in an orderly manner and meet quality standards
• Leads validation personnel or projects, when assigned
• Records information and observations from internal audits to support the preparation and distribution of internal audit reports
• Establishes and maintains quality policies and programs within the IT area to ensure proper document and data control methods are utilized
• Interfaces with client QA departments and attends sales presentations and business reviews to support the coordination of client activities
• Interacts with internal auditors to discuss audit plans and findings
• Ensures continued learning of new/existing regulatory requirements by the various regulatory bodies governing our healthcare industries
• Participates in consultations with Corporate Legal to determine compliance implications of pending business
• Ensures consistent and timely completion of compliance-base tasks as assigned including but not limited to NCs, CAPAs, Audit findings and Document Changes/Management
• Follows up with clients after audits to identify issues and mutually acceptable solutions

PDS Tech Commercial, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Founded in 1977, PDS Tech, Inc. is one of the nation's premier specialty staffing firms with 31 offices nationwide. We offer a full range of benefits including:

• Health insurance
• Paid holidays
• Weekly payroll
• Immediate 401(k) eligibility
• Completion Bonuses
• Training
• Please note availability of benefits may vary by position

PDS specializes in Engineering and IT arenas including Aerospace, Defense, Electronics, Telecommunications, Automotive, and Energy just to name a few. Our reputation, track record, and years of continuous growth reflect the commitment to quality that our employees and clients experience first-hand. To find out more about PDS, please visit www.pdstech.com

$$$ PDS pays for referrals! $$$

We pay thousands each month in referral bonuses!
Contact a recruiter for details. To find one near you, take a look at where we are.

If you have questions, please click here to contact us.

PDS Tech Commercial, Inc. is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities.
If you need special assistance or an accommodation while seeking employment, please click here or call 1-800-270-4737 to contact us. We will make a determination on your request for reasonable accommodation on a case-by-case basis.

The law requires PDS Tech to post a notice describing the Federal laws prohibiting job discrimination. For information regarding your legal rights and protections, please click on the following links: EEO is the Law and EEO is the Law Supplement

PDS Tech will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. Please see the Pay Transparency Nondiscrimination Provision for more information.

As a Federal Contractor, PDS Tech is required to participate in the E-Verify Program to confirm eligibility to work in the United States.
For information please click on the following link: E-Verify