Quality Systems Specialist (Pharmaceutical Validation)

Roth Staffing is looking for Quality Systems Specialist (Pharmaceutical Validation & Compliance) with cGMP, FDA regulations, validation protocols, CAPA, RCA, FMEA, SOPs. This is 12 months temp-contract role Hourly Pay Rate: $32.00 -to- $35.00, * Writes, reviews, approves and/or executes documentation for new and current validation procedures and technical reports related to systems, products and/or processes.

• Conducts quality control for statistical analyses of testing results and process anomalies.
• Ensures that corrective measures meet acceptable reliability standards.
• Verifies calibration, maintenance and repair of instruments as applicable to support the Quality Systems validation program.
• May evaluate quality and system standards to ensure reliability and compliance with company standards and government regulatory requirements.

Responsibilities:

• Maintain a thorough understanding of the relevant regulations and guidelines: Food & Drug Administration (FDA), Clinical Laboratory Improvement Amendments (CLIA), current Good Manufacturing Practices (cGMP), corporate policies and procedures, FDA’s guidance on Validations, all relevant Medical Device Directives, and other applicable standards.
• Under direct supervision, assists in preparation, execution, data collection and reporting of validation studies to ensure the user needs and specifications are consistently met.
• Prepares validation protocols and test equipment; evaluates validation test data.
• Prepares reports on completed studies that summarize test results and their conformance to defined acceptance criteria.
• Assists in developing programs and maintaining standard operating procedures (SOPs) validations.
• May provide support related to management of procedural documents.
• Communicates cross functionally regarding needs and status of assigned study activities and project deliverables.
• Perform other job-related duties as assigned.

• Bachelor’s Degree in Sciences or Engineering or equivalent combination of education, training and relevant work experience required
• ASQ Certification preferred
• 0-3 years’ related quality/validation experience in pharmaceutical manufacturing/a highly regulated industry
• In-depth working knowledge of cGMP principles and applications
• Demonstrated ability writing and approving documents, which help explain technologies, processes and products including validations
• Participating in FMEA or RCA/CAPA development teams
• Understand regulatory standards, various local, state and federal laws that apply to the business and where to find information on standards and interpretations
• Excellent negotiating, critical reasoning, decision-making, and problem solving skills to analyze situations, determine risks, find solutions to prevent future issues and resolve recurring defects
• Strong project management and organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives
• Strong written and verbal communication, interpersonal and presentation skills to drive results
• Establish solid working relationships to interface with other business units, third parties and other positions and circumstances within the organization
• Demonstrates excellent customer service skills with the flexibility to respond to changes quickly
• Maintain a professional demeanor and handle confidential information with discretion
• Computer literate with proficiency in office applications, word processing, spreadsheets, graphics and statistical programs, and use of electronic quality and operational systems
• Understands complex problems to collaborate and explore alternative solutions
• Ability to make decisions which have significant impact on the immediate work unit and monitor impact outside immediate work unit
• Attention to detail and ability to follow written and verbal directions in exact detail required