Quality Assurance Specialist

Position Summary:

Specialist I, Quality Assurance 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.

Duties & Responsibilities:

• Assist in the authoring, revision, review, and approval of SOPs, Client Operating Protocols (COPs), Policies, and training materials under guidance.
• Support the review and approval of GMP and non-GMP records, including preventative maintenance, pest control, and facility walkthroughs.
• Participate in authoring and tracking Corrective and Preventive Actions (CAPAs), ensuring timely completion with supervision.
• Assist in the preparation of deviation and investigation reports, perform Root Cause Analysis (RCA) under guidance, and notify Clients as required.
• Perform Quality oversight of Warehouse/Operations which include:
• 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.).
• Assist in monitoring internal laboratory operations and review laboratory records to assure compliance with internal SOPs and cGMP requirements.
• 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.
• Perform and document line clearance.
• Provide quality oversight over internal/external validation and calibration activities and documentation in compliance with Sentry’s Validation Master Plan, SOPs, and applicable regulations.
• Support supplier qualification processes by maintaining records and assisting in audit activities.
• Help maintain federal and state licenses, ensuring timely renewals and reporting statuses.
• Support and participate in internal, Client, and regulatory audits/inspections.
• Assist in training new Quality Assurance staff.
• Assist Quality Management in developing and reporting quality metrics.
• Periodically carry on-call phone and respond to after-hours 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 two (2) years of QA/QC experience in a pharmaceutical, biotech, medical device, or other regulated industry.

Computer Skills:

To perform this job successfully, an individual should have proficient knowledge of Microsoft Office (Word, Excel, Outlook), web browsers, barcoding systems, electronic Quality Management Systems (eQMS), and quick ability to learn new software.

Language Skills:

Ability to read and interpret documents such as regulatory, safety rules, training manuals, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence.

Mathematical Skills:

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percentage and to draw and interpret bar graphs.

Reasoning Ability:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. The ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to stand, walk, use hands to handle or feel, talk, and hear. The employee is frequently required to reach with hands and arms; climb or balance; and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly exposed to moving mechanical parts. The employee is frequently exposed to cold/freezing conditions. The employee is occasionally exposed to high, precarious places; fumes or airborne particles; outside weather conditions; heat and vibration. The noise level in the work environment is within OSHA regulations.