Quality Analyst II

Role Summary

Quality Analyst II responsible for providing QA support to Manufacturing, Supply Chain, and Quality Control Laboratories. Responsible for reviewing and approving QA methods, procedures, protocols, investigation documents, and change control documents. Uses trend and investigational data to improve processes and reduce failures, while representing the quality department on cross-functional teams.

Responsibilities

• Responsible for providing a thorough and timely review and approval of cGMP documents and processes such as deviations, investigations, equipment and facilities maintenance and calibration, protocols and reports, and facility controls, instruments and procedures.
• Work with operating departments to facilitate process improvements and lean concepts.
• Participate in cross-functional improvement and process monitoring teams to mitigate unfavorable trends.
• Provide first response and ongoing QA presence for quality and compliance issues on the manufacturing floor and in laboratories as needed.
• Evaluate reports of deviations from defined processes and determine if incidents should be escalated to an event investigation.
• Conduct comprehensive investigations of complex and/or challenging events as assigned.
• Complete actions to document investigations, identify root causes, create and assign CAPAs, and gain approval and closure of an event.
• Investigate critical events, supporting other quality team members in analysis and documentation.
• Compile and maintain metrics and tracking logs for site quality KPIs or other functions.
• Support activities within electronic systems as needed (e.g., LIMS, TrackWise, EAM).
• Serve as QA backup for final review/release of production batch records.
• Complete training requirements and maintain compliance with all assignments.
• Maintain work areas and perform job functions safely and efficiently in accordance with company policies, cGMP, SOPs, and batch record instructions.
• Perform additional related duties as assigned.

Qualifications

• Requires a Bachelor‚Äôs Degree or equivalent with a minimum of three years of relevant progressive QA experience in the pharmaceutical or related industry.
• Prefer degree in Science or Engineering.
• Requires experience with cGMP and other applicable regulatory requirements related to production of pharmaceutical products and quality systems.
• Requires experience handling deviations, investigations, and CAPAs.
• Experience with manufacturing/quality systems such as TrackWise, Labware, Veeva, Learning Management Systems and statistical software preferred.
• Experience with laboratory-related investigations/inquiries preferred.
• ASQ/CQE/CQA Certification preferred.

Skills

• Detail-oriented with ability to analyze information and create performance metrics.
• Computer proficiency with MS Office and relational databases.
• Sound judgment and decision-making abilities.
• Ability to build and maintain collaborative relationships across teams and units.
• Excellent written and oral communication skills.
• Positive collaboration with co-workers, management, and external partners.
• Conflict management and negotiation skills.
• Self-directed with ability to organize and prioritize work.

Education

• Bachelor‚Äôs Degree or equivalent; three years of QA experience in pharmaceutical or related industry.
• Science or Engineering degree preferred.
• Relevant certifications (ASQ/CQE/CQA) preferred.

Additional Requirements

• Physical requirements and travel: see job description for details; includes frequent and occasional physical activities as described.