Position Summary:The Spear Group is seeking a dedicated Quality Specialist to support our pharmaceutical manufacturing operations by providing expert quality oversight across production, laboratory, maintenance, and environmental monitoring functions. This role is critical in ensuring compliance with cGMP standards, supporting investigations and CAPAs, and serving as a quality partner for multiple departments. The ideal candidate will have hands-on experience with quality systems, data integrity, SAP, and regulatory audits. The Quality Specialist will also contribute to aseptic process simulations, batch record review, risk assessments, and internal training while fostering continuous improvement and team development. This is a highly collaborative position suited for a proactive professional passionate about quality and operational excellence.

Key Responsibilities:

• Provide quality support to various groups including Operations, Technical Ops, Maintenance, and Environmental Monitoring to assess impact of atypical situations and provide the right compliant guidance and impact to issues from a quality perspective.
• Serve as quality partner on several quality notifications (incidents, investigations, and CAPAs) in SAP to review and approve excursions related to production, laboratory, environmental monitoring, maintenance, supplies inspection, cross contamination, and materials management.
• Provide 100% on-time review and approval with no delays or overdue tasks.
• Serve as quality partner to act as a Data Integrity Representative for the factory.
• Provide training and second person review for three Quarterly Trend reports.
• Support aseptic process simulations.
• Volunteer to support aseptic observations in graded A/B space.
• Help with APS protocol review and approval, scheduling, atypical events, and CAPAs.
• Support several internal audits, divisional audits, and agency audits in many capacities as QA shopfloor SME, walking tour route, and/or as a notetaker (scribe).
• Respond to observations as necessary in QSAT tracker.
• Lead continuous improvement in processes and fix issues to eliminate potential of regulatory observation.
• Support Release Schedule Adherence (RSA), streamline batch record review, eliminate delays, and standardize approval within 14 days from DOM.
• Collaborate in quality risk management as SME or quality partner for several Quality Risk Assessments (QRAs) related to particulate reduction, cross-contamination, liquid antibiotic, sterile operations, and lab equipment in Factory 7.
• Help with memos to stay compliant.
• Support site-wide Kaizens.
• Plan, execute, and sustain projects with cross-functional teams including several functions at different levels.
• Perform GEMBA audits, document observations, assign action items, and follow through with resolution.
• Investigate Product Quality Complaints (PQCs) received from customers from different countries.
• Plan improvements for antibiotic containment under various work streams to meet agency expectations.
• Author/review and approve standard operating procedures, memos, job aids, and regulatory protocols and provide second person review as needed.
• Support a team of 5 employees by providing perpetual coaching and ensuring progression of knowledge and skills.
• Provide support as interim QA in other areas as needed to manage day-to-day assignments.
• Interview and onboard new employees.
• Develop employees via continued staff meetings and one-on-ones to ensure tasks are realized and completed.
• Have developmental discussions that enable growth of employees.
• Facilitate cross-training between bulk manufacturing and finished filling.
• Help understand responsibilities of each employee, provide ownership of tasks, and distinguish roles of different levels (contractors, P1s, and P2s).

Required Experience and Education:

• Bachelor degree or higher in Chemistry, Chemical Engineering, Pharmacy, Biology, or Regulatory Affairs required.
• Two years of quality assurance experience in the pharmaceutical industry required, including any experience with quality assurance systems, quality assurance control (including regulatory requirements), SAP, and project management.

Must have legal authority to work in the U.S. EEOE.
Send resume to: Barbara LaCasce at barbara.lacasce@speargroup.com. Please reference DG22 + job title in subject line.