Senior Quality Specialist

Operations Supervisor

Responsibilities: <ul><li>Point of Contact for all quality matters, enquiries, and support to both internal and external customers</li><li>Develop, implement and align quality strategies to ensure processes and procedures meet quality excellence standards</li><li>Lead and mentor colleagues at sales operations offices, fostering a culture of excellence and accountability</li><li>Oversee the management of ISO 9001:2015 and quality system (CAPA, Change Management, Investigation, etc.)&nbsp;</li><li>Manage, own and investigate product complaints</li><li>Business Process Owner for Document Control</li><li>Analyse and track quality metrics such as Complaint KPI</li><li>Conduct/Host audits (internal and external) and inspections to ensure compliance with regulatory, quality and internal standards</li><li>Manage and negotiate quality agreements with end customers, group legal and global quality&nbsp;</li><li>Support quality documentation requests from customers</li><li>Ensure documentation and traceability of quality processes and corrective actions</li><li>Facilitate quality management reviews and relevant quality meetings</li><li>Manage supplier quality and conduct vendor assessments when necessary</li><li>Collaborate with cross-functional teams (e.g., global supply, sales, global quality, support teams) to resolve quality issues</li><li>Stay updated on industry trends, standards, and regulatory changes (where required)</li><li>Drive continuous improvement initiatives using Lean, Six Sigma, or other methodologies</li></ul> Requirements:﻿ <ul><li>Bachelor’s degree in Biological Sciences, Quality Engineering, or related fields</li><li>5+ years of experience in quality assurance, quality compliance, supplier quality or quality operations&nbsp;</li><li>Strong knowledge of QA methodologies, tools, and standards (e.g., ISO 9001:2015, ISO 13485, cGMP/GxP relevant)</li><li>Auditor certification in quality standards preferred</li><li>Strong knowledge in investigation and RCA methodology, and technical writing skills</li><li>Proficiency in quality management systems softwares (e.g., Trackwise)</li><li>Excellent analytical, problem-solving, and decision-making skills</li><li>Strong communication and interpersonal skills</li><li>Able to work in fast-paced, dynamic environments</li><li>Detail-oriented with a strategic mindset</li><li>Independent, Proactive and Task-driven</li><li>Leadership experience preferred</li></ul>

Role Description: <ul><li>Job Summary The Operations Supervisor is responsible for overseeing solid dosage pharmaceutical manufacturing and packaging activities during 2nd shift operations, 3:15pm to 11:45pm.&nbsp;</li><li>This role ensures that all production operations comply with cGMP, safety standards, and production schedules.</li><li>The operations supervisor will lead and support a team of leads and operators ensuring high quality output, operational efficiency, and a safe working environment.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Oversees and coordinates Manufacturing and Packaging operations.&nbsp;</li></ul> Responsibilities: Key Accountabilities: <ul><li>Accountability Lead and supervise operations in solid dosage manufacturing and packaging to ensure adherence to Master Formula and Master Packaging Records, SOP’s, and regulatory requirements (FDA, etc.).</li><li>Communicate with department leadership, set the shift schedule, and conduct shift huddle/communication at start of shift to ensure effective communication between shifts.</li><li>Ensure timely execution of production schedules.</li><li>Monitors manufacturing and packaging processes to ensure schedule is met within standards.</li><li>Review and complete shift documentation, including batch documentation, logbooks, etc.</li><li>Coordinate with Engineering and Quality Assurance to address any equipment issues that occur during the shift Support investigations for deviations that occur during the shift.</li><li>Assist in determining and implementing CAPA.</li><li>Provide training, guidance, and performance feedback for shift employees.</li><li>Ensure training requirements are met.</li><li>Support employee development and cross-training.</li><li>Executes procedures to complete tasks in a compliant and safe manner.</li></ul> Continuous Improvement <ul><li>Captures and reports metrics; troubleshoots downtime to increase operational efficiency.</li><li>Lead or participate in Continuous Improvement projects.</li><li>Troubleshoots and resolves process issues.</li></ul> Issues &amp; Deviations <ul><li>Performs defect evaluations and initiates production events.</li><li>Identifies, reports, and suggests resolutions for processing related issues.&nbsp;</li><li>Assists in the investigation of unplanned deviations.</li></ul> Teamwork and Collaboration <ul><li>Provides priorities for the off-shift operations, focusing resources on priority products.</li><li>Interfaces with supervisors and/or Quality personnel to inform of deviations or other line issues.</li><li>Continuous Training Ensures personnel are current with training requirements.</li><li>Stays current on SOPs and cGMPs.</li><li>Continuous Safety &amp; Compliance Contribute to safety audits.</li><li>Ensures out manufacturing/packaging activities safely, as required, on a daily basis.</li><li>Follows all safety and compliance procedures and participates in required training.</li><li>Adheres to all cGMP compliance/regulatory mandates and quality requirements.</li><li>Participate in safety teams, start-up discussions, incident debriefs, etc.</li><li>Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies.</li><li>Misc Other related duties as assigned to meet departmental and Company objectives.&nbsp;</li></ul> Requirements: Qualifications Education &amp; Experience: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job Bachelor’s degree in pharmacy, Chemistry, Engineering, or a related discipline preferred, relevant experience my substitute.</li><li>Minimum of 3 years supervisory experience in pharmaceutical solid dosage manufacturing/packaging.&nbsp;</li><li>Knowledge Proficiency in a body of information required for the job e.g.</li><li>Knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Thorough knowledge of cGMP and FDA regulations.</li><li>Thorough knowledge of manufacturing and packaging operations.&nbsp;</li></ul> Skills &amp; Abilities: <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Demonstrated leadership, communication, and decision-making skills.</li><li>Ability to oversee and manage the daily operations of manufacturing and packaging. Ability to monitors processes to ensure schedule is met within standards.</li><li>Ability to analyze metrics and troubleshoot downtime.&nbsp;</li><li>Effectively interfaces with Quality Assurance to inform of deviations or other line issues.</li><li>Demonstrates the ability to work in collaboration with others as a part of a team.</li><li>Ability to lead in Continuous Improvement projects.</li><li>Possess technical writing skills.&nbsp;</li><li>Physical Requirements Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.</li></ul>

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Senior Quality Specialist

Operations Supervisor

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Senior Quality Specialist

Operations Supervisor

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