Job Description

Position Summary

Quality Engineer II-III, Quality Assurance is responsible for designing, implementing, and maintaining the Quality Management System across the manufacturing lifecycle. This role supports process validation; root-cause investigations for deviations; oversees Corrective and Preventive Actions; and ensures compliance with current Good Manufacturing Practices. This position is responsible for monitoring and control the quality processes supporting incoming, in-process and final disposition including batch record review and release for GMP, clinical, and commercial programs through broad knowledge of GLP/GMP manufacturing theories and principles. This position works closely with other functional areas of the Company to release raw materials, per agreed upon timelines. Additional areas of responsibility include QA oversight of operational metrics and supporting client and internal auditing activities. The Quality Engineer II-III, Quality Assurance shall adhere to the Company’s quality system including but not limited to the applicable standards, policies and procedures in the areas of responsibility defined in this job description.

Essential Functions

• Regulatory Compliance: Ensure all production practices strictly align with FDA 21 CFR Parts 210/211, ICH Q10, and global cGMP standards.
• Validation & Qualification: Quality Assurance review and approval of validation protocols (IQ/OQ/PQ) for manufacturing equipment, facilities, utilities, and analytical laboratory software.
• Deviation & CAPA Management: Support investigation of manufacturing deviations and out-of-specification (OOS) results using root-cause analysis tools like 5 Whys and Fishbone diagrams.
• Documentation: Quality Assurance review and approval of manufacturing documentation, including specifications, batch records, and batch release.
• Risk Assessment: Support Quality Risk Management (QRM) initiatives utilizing Failure Mode and Effects Analysis (FMEA) to minimize patient and product risk.
• Change Control Oversight: Evaluate and approve change controls for processes, materials, or equipment to ensure they do not negatively impact product quality.
• Audit Support: Conduct routine internal audits and manage readiness documentation for external regulatory agency inspections.
• Supplier Quality: Partner with procurement to audit third-party raw material suppliers and manage external quality issues.
• Oversee the quality management processes ensuring that client requirements, specifications, and regulatory requirements are met by the Operations Unit.
• Collaborate with cross-functional teams, including production, engineering, supply chain, and customer service, to address quality issues and drive continuous improvement initiatives.
• Analyze quality data and performance metrics to identify trends, root causes of defects, and opportunities for process optimization.
• Partner with Operations supporting closure of Quality Events and quality improvement plans when needed.
• Conduct regular audits to monitor compliance with quality standards and identify areas for improvement.
• Routinely draft and revise standard operating procedures and QA review of master batch records.
• Leads internal and supports external audits in accordance with Company procedures and schedules. Develop reports of audit findings and communicate these to the relevant project team and to Company management

Direct Reports: No

Indirect Reports: No

Key Relationships (examples: Depts or Individual positions that this position will be working closely with):

• Manufacturing Operations
• Warehouse
• Quality Control

Travel requirements

• N/A

Education and Experience

• B.A. / B.S. in a Engineering discipline, or equivalent experience preferred
• Quality Assurance experience in the pharmaceutical industry for 5 +years

Knowledge, Skills, and Abilities

• Knowledge of Pharmaceutical Quality Management Systems requirements and execution
• Demonstrated proficiency in written, verbal and face-to-face communication to effectively present information to internal and external customers
• Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining high attention to detail while responding to rapidly changing priorities and aggressive deadlines
• Technically capable of identifying root cause of a problem, offering potential solutions, and engaging with others to resolve the problem
• Produces consistent, high quality and quantity of outputs and meaningful results that contribute to the agency mission and strategic goal. Is efficient in producing results that are delivered on time or before.
• Ability to work independently and as part of a team
• Expertise in MS Office (Excel, Word, Outlook, Project) and Adobe Pro

Physical Demands and Work Environment

While performing the duties of this job, there may be certain physical demands required for the position.

• Requires frequent standing
• Requires constant walking
• Requires occasional sitting
• Requires frequent carrying, bending, twisting, reaching, & gripping
• Requires frequent lifting, pushing, & pulling 20-60 LBS

Other Duties

You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.

Limitations and Disclaimer

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.

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