What are the responsibilities and job description for the Quality Systems Validation Specialist position at WuXi AppTec?
Overview
The Quality Systems (QS) Validation Specialist serves as a key resource for providing oversight and guidance to ensuring equipment and computerized systems (CSV) compliance with applicable standard and regulatory requirements, along with site operations, policies, procedures, processes to mitigate process and/ or product risks at WuXi AppTec St. Paul.
This position will support multiple aspects within the Quality organization with focus on but not limited to: equipment and computerized systems validations, supplier quality functions, SOP writing and review, Quality event review, and auditing support.
Position Details
- Schedule: Monday to Friday standard business hours
- Location: Mendota Heights, MN
- Anticipated Compensation Range: $60,410 to $78,270
- Benefits: Comprehensive employee benefits package including Health, Vision, Dental, 401k Matching, and Paid Time Off
Responsibilities
• Contribute to the writing, coordination, review, approval and maintenance of equipment related Policies and Standard Operating Procedures (SOPs).• Support with equipment deviation and nonconforming events management to ensure accurate reporting, investigation, root cause analysis and corrective actions.• Resource for equipment qualification and validation through quality systems (i.e. MasterControl, Non Conformances (NCE), Deviations, Corrective Action/Preventive Action (CAPA), Complaints, Supplier Program, and Change Control).• Create, execute and review equipment qualification/validation, data integrity, IQ/OQ/PQ. Support test method verification/validation and computerized systems validation as it relates to the equipment being qualified/validated. • Assists with supplier qualification activities as it relates equipment or equipment related acquisition or services. Assist with equipment related supplier quality activities including Supplier Corrective Action Reports (SCARs), and assessing suppliers for technical, quality capabilities and performs risk base assessments.• Provide QA input to functional groups to evaluate and ensure proper closure of deviations, investigations, complaints, change controls and CAPAs related to equipment.• Support internal and external audits and regulatory inspections. • Ability to work in a team environment and independently.• Contributes to the overall operations and to the achievement of departmental goals• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.• Other duties as assigned. May be required to assist in other departments.
Qualifications
• Knowledge of 21 CFR Part 11 is required. Knowledge on 21 CFR Part 58, 211, 820 highly desirable.• Knowledge of GLP, GMP, ISO 13485 and ISO 17025 are highly desirable.• Experience writing and executing qualification/validations of equipment and computerized systems.• Preferred 2-4 years of experience in medical device or other regulated industry.• Bachelor’s or Associate’s degree preferable in Engineering, Computer Sciences or related field.
Knowledge / Skills / Abilities:• Demonstrated knowledge of CSV/Validation and Quality Systems• Excellent verbal and written communication and interpersonal skills. Ability to work collaboratively across all functional groups and all levels.• Highly motivated, goal oriented achiever with ability to prioritize and organize own work independently• Excellent problem-solving skills• Experience working with Electronic Document Management systems• Computer skills; working knowledge of MS Excel, Word, Outlook, etc.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
Salary : $60,410 - $78,270
