Specialist; QA Compliance (Computer Systems)

Hauppauge, NY (http://maps.google.com/maps?q=135+Adams+Avenue+Hauppauge+NY+USA+11788)

Apply

Description

Position Summary:

The Specialist of Quality Assurance Compliance (Computer Systems) is responsible for providing system administration oversight for 21 CFR Part 11 Computer Validation Systems (CVS). This includes reporting and management of events and items coordinated through these CVSs to ensure GMP compliance. Additionally, the Specialist will support the QA Compliance Audits, Investigations, Document Control and Stability groups as needed.

Responsibilities:include but are not limited to:

• Provide system administration oversight of CPC’s 21 CFR CVSs e.g. MasterControl, DEACOM, Empower.

• Administration of user accounts and user right access for CVSs.

• Ensure overall system data integrity for applicable CVSs.

• Lead report generation for the purpose of Quality Review Board, Facilities Compliance Reports, FDA and other audit inspections.

• Oversee the compliance to CPC SOP of related CVS elements, example reporting and follow up on on-time closure of quality events in MasterControl.

• Lead all computer validation activities including all activities related to validation documentation.

• Spearhead software configuration for CVSs.

• Coordinate continuous improvement projects and new implementations related to CVSs.

• Create and/or review related SOPs and other cGMP documentation as needed.

• Approve Change Controls related to the aforementioned areas.

• Support all aspects of the QA Compliance department including SOPs, training review and management, investigations, audits, document control, stability, etc.

• Other projects and duties as assigned by management.

Requirements

Education and Experience:

• Bachelor’s degree in computer science or computer engineering, or a bachelor’s degree in a science or engineering field with a minor in computer related studies.

• At least 1 year of experience in a pharmaceutical GMP setting preferred.

Skills, Abilities and Knowledge:

• Strong data analysis skills and proficient in related data analysis techniques and computer programs.

• Some working knowledge of basic computer programming, such as Java, Python, SQL etc.

• Knowledge of computer program validation principles.

• Familiarity with, or ability to quickly learn, US FDA and EU EMEA cGMPs for pharmaceutical and supplement manufacturing.

• Understanding of, or ability to quickly learn, Pharmaceutical Quality Systems.

• Effective written and oral communication skills to all employee levels.

• Excellent technical writing skills and attention to detail.

• Ability to manage multiple tasks and meet deadlines.

• Proficient in Microsoft Office applications.

• Required training in SOP, cGMP, and General Safety procedures.

Physical Demands:

• Required to use hands to handle or feel objects, tools, computer controls.

• Specific vision abilities required include close vision, ability to focus.

• Regularly required to sit, stand, or walk for long periods; may be required to lift up to 50 lbs.

Work Environment:

• Required to be present in the office to collaborate with managers, directors, peers and other departments daily.

• Responsible for adherence to safety policies.

• Employee travel/work hours/schedule/location and/or shift are subject to change based on business needs and Management discretion.

• Regular, ongoing travel throughout geographic areas on a continual basis as normal scope of role.

Supervisory Responsibilities:

• None

Personal Protective Equipment or Attire Required for Position:

• As needed

Pay Range:

$50,000 - $65,000 per year