Senior Specialist

Senior Specialist, Quality Assurance independently initiates, tracks, and drives the completion of assigned functions within the Quality Management System in accordance with cGMP, regulations, and Sentry standards. Additionally, provide support, guidance, and recommendations regarding the compliance of operational, validation, maintenance, and laboratory tasks.

Essential Duties & Responsibilities:

• Author, revise, review, and/or approve SOPs, Client Operating Protocols (COP), Policies, and training material.
• Author, review, and/or approve GMP and non-GMP records (preventative maintenance, pest control, facility walk throughs, etc.).
• Author, drive implementation, and check the effectiveness of CAPAs. Track open CAPAs, ensuring timely completion, and/or requesting for extensions as applicable.
• Author deviation and investigation reports related to quality system failures, perform Root Cause Analysis (RCA), perform required Client notifications, and evaluate impact to SISPQ. Track all open deviations, ensuring timely completion, and/or requesting extensions as applicable.
• Perform Quality oversight of Warehouse/Operations which includes:
• Coordinating appropriate QA coverage for routine verification of receipts and shipments.
• Monitoring incoming client orders (inbound and outbound) for errors and interfacing with Sentry clients for corrections (non-conformance notice), as needed.
• General Quality duties in Warehouse Management System (status changes, expiration date changes, approving new items, etc.).
• Support Manufacturing Operations. This includes but is not limited to:
• Perform/Review internal material releases on labels, drug products, etc.
• Assist with batch record development, execution, or review.
• Act as a performer or verifier for labeling and packaging operations.
• Perform statistical QA verification of labeled and packaged products.
• Provide quality oversight over internal/external validation and calibration activities and documentation in compliance with Sentry’s Validation Master Plan, SOPs, and applicable regulations.
• Oversee the supplier qualification program. This includes but is not limited to:
• Tracking the status of all supplier qualifications and ensuring requalification’s are performed on time.
• Performing paper audits of all necessary suppliers and ensuring all necessary records are on file.
• Assist QA Management with physical audits of suppliers, as requested.
• Maintain federal/state licenses and related documents required by various entities for Sentry’s business. Ensure the timely submission of license renewals and report status to Quality Management.
• Support and/or host internal, Client, and regulatory audits/inspections.
• Assist in the development and reporting of quality metrics.
• Provide training to staff on quality-related procedures and standards to ensure a consistent understanding of quality requirements.
• Assist in training new Quality Assurance staff.
• Assist Quality Management in developing and reporting quality metrics.
• Periodically carry on-call phone and respond to afterhours alarm situations.
• Additional duties as assigned by manager.

Competencies:

• Self-motivated with minimal need for supervision.
• Ability to multi-task and manage time effectively under pressure.
• Effective time management.
• Excellent attendance and punctuality.
• Detail-oriented with strong organizational skills.
• In-depth knowledge of GMP regulations and reporting requirements.
• Commitment to continuous improvement and adaptability to change.
• Understanding of job functions and their relation to other roles within the organization.
• Excellent verbal and written communication skills, with the ability to develop rapport at all organizational levels.
• Results-driven with personal initiative and perseverance.
• Excellent teamwork and collaboration skills.

Education and/or experience

Required: BA or BS in a science/technical field and five (5) years of QA/QC experience in a pharmaceutical, biotech, medical device, or other FDA-regulated industry.

Location: Indianapolis, IN

Department: Quality Assurance

Schedule: Full Time, On-Site

Education: BS or BA in Science/technical field (Required) 

Experience: 5 Years of QA/QC in pharmaceutical, biotech, medical device, or other FDA-regulatory industry