Sr Quality Engineer

Role Summary

Sr Quality Engineer – This position provides Quality Assurance support to Manufacturing, Supply Chain and Quality Control Laboratories, including QA review/approval of methods, validation/transfer protocols, investigation documentation, and change control. Leads cross-functional teams to track/investigate data and drive process improvements and failure reduction. Represents quality management across the site.

Responsibilities

• Provide thorough and timely review/approval or author/execution of cGMP documents and processes (deviations, investigations, equipment and facilities maintenance and calibration, protocols and reports, facility controls, instruments, procedures).
• Collaborate with operating departments to facilitate process improvements and lean concepts.
• Lead 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 deviation reports and determine if incidents should be escalated to an event investigation.
• Conduct comprehensive investigations of critical/complex events as assigned.
• Serve as QA lead on R&D products and related document reviews/approvals, including change control items, protocols, batch records and deviations as applicable and product disposition.
• Work with laboratory to investigate OOT and OOS events, providing feedback and manufacturing information.
• Compile and maintain metrics and tracking logs for site quality KPIs.
• Support internal/external audits of operational areas.
• Support activities within electronic systems (LIMS, TrackWise, EAM).
• Serve as QA backup for final review/release of production batch records, manage site change control system, and support validation/qualification protocols.
• Complete training and maintain compliance with all assignments; maintain safe and efficient work areas in accordance with cGMP, SOPs, and batch records.
• Perform additional related duties as assigned.

Qualifications

• Requires a bachelor‚Äôs degree or equivalent with at least seven years of progressive QA experience in the pharmaceutical or related industry.
• Preferred degree in Science or Engineering.
• Preferred experience in a solid dose manufacturing environment.
• In-depth knowledge of cGMP and applicable regulatory requirements related to pharmaceutical production and quality systems.
• Experience handling deviations, investigations, and CAPAs.
• Experience managing partner relationships preferred.
• Experience with manufacturing/quality systems (TrackWise, Labware, Veeva, LMS) and statistical software preferred.
• Experience with laboratory investigations/inquiries preferred.
• ASQ/CQE/CQA certification preferred.

Skills

• Detail-oriented with ability to analyze information and create performance metrics.
• Proficient with MS Office and relational databases.
• Sound judgment and decision-making abilities.
• Ability to build collaborative relationships across teams and functions.
• Ability to motivate, influence, and lead others.
• Effective written and oral communication; able to interact with co-workers, management, and external partners.
• Conflict management and negotiation skills.
• Self-directed with strong organization and prioritization; project management and advanced presentation skills preferred.

Education

• Bachelor‚Äôs Degree or equivalent; seven years of QA experience in pharma or related industry.
• Prefer degree in Science or Engineering; preferred experience in solid dose manufacturing.

Additional Requirements

• Travel: N/A
• Physical requirements: Frequent and occasional lifting, standing, walking, repetitive motions, visual acuity for data analysis and inspection; PPE as needed in production areas.