Quality Control Compliance Specialist

GreetingsHope You are doing great!This is Archana, Sr. Technical Recruiter with Experis - Part of Manpower Group. Please find below Job details and respond if you would be interested.

• This role is responsible for supporting compliance in the Quality Control Analytical Laboratory, including authoring, management and/or tracking of investigations/events/deviations, Corrective Action / Preventive Action, change control, and other Quality records.
• This position will facilitate the compiling, trending and reporting of key quality metrics for management accountability, and other quality control functions, as needed. Continuously monitor systems, logbook management, and testing procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products.
• Supports and ensures timely initiation, write up and closure of QC CAPAs, Investigations, Deviations and Change Controls.
• Responsible for tracking and trending aspects of Quality Control Systems and provide reports to management identifying risks and trends on a routine basis.
• Works with Quality Systems group to perform QC CAPA effectiveness evaluation based on quantitative and qualitative measurements.
• Maintains tracking mechanisms to support various QC related analytical metrics.
• Continuously monitor and review QC systems and procedures for adherence to regulatory compliance, quality improvements, efficiency and industry best practices. Provide compliance support and expertise for QC department.
• Participate in QC compliance remediation plans and implementation.
• Assists with the generation and/or revision of GMP documentation such as standard operating procedures.
• Establish and execute laboratory audit readiness program to ensure a compliance ready state at all times in the laboratory.
• Participates in QC internal audits, as applicable.
• Participate in site quality and process improvement initiatives. Represent QC Analytical on-site project teams.
• Provide protocol generation and execution support for critical facility and utility qualifications and startups.
• Other duties, as assigned.
• Experience with Good Manufacturing Practices (GMPs)
• Experience with the development / review / approval of CAPAs / Deviations / Investigations within the pharmaceutical/ biologics industry, especially within the Analytical / Bioanalytical laboratories
• Experience with ICH Guidelines / USP / EU GMPs
• Ability to quickly learn and navigate electronic systems
• Able to work in a team setting and independently under minimum supervision
• Requires the ability to work and produce results in a fast-paced environment
• Creative individual with excellent trouble shooting skills
• Timeliness and accuracy in completion of tasks
• Contributions to the team beyond general responsibilities
• Identification of areas for improvement and leads implementation strategies for improvement
• Exercises good judgment
• Demonstrated understanding and adherence to Paragon policies and procedures
• Ability to succeed in a team-oriented environment under dynamic conditions
• Minimum of a B.S. in a Life Sciences discipline
• +8 years' experience within the biologic, biopharmaceutical, or regulated pharmaceutical Quality Control Laboratory
• 1-2 years' experience in Quality / Compliance function, or significant participation with investigations/deviations/events/etc., within the laboratory setting
• Experience with the analytical and/or bioanalytical testing process
• Have the knowledge, and ability to apply basic scientific and regulatory principles to improve quality systems
• Exposure to Lean Operational Excellence highly desirable
• Experience working in electronic systems such as LIMS, EDMS, ERP desirable