Senior Specialist - Quality

Job Description

The Lyo Quality Operations group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Senior Specialist, Quality Operations, with guidance from the Integrated Process Team Quality Operations Leader, ensures product/process quality through the review of Good Manufacturing Practice documents, facilities and processes and performs activities to ensure the reliable release of quality products to the marketplace.  This role is responsible for ensuring adherence to Divisional, Company and Site policy, procedures and guidelines. This position requires strong quality, scientific, and communication skills.  Strong collaboration and decision making are key attributes. Primary activities include:

Primary Activities:

• Acts as a Quality Operations representative for the Lyo IPT. As such, this individual must have sound knowledge of a wide variety of process, analytical, instrument and automation disciplines associated with operations.  This individual is accountable for the shared operations, quality and technology objectives for their area within the Integrated Process Team, including deviation and discard reduction, schedule adherence, cycle time reductions and right first time.  Coordinates and executes all Quality Operations activities to ensure production plans are met, utilizing the tier process.  Supports project work in the building.

• Manages aspects of the material control and/or release process as it relates to control of material for deviations, risk processing and change control.

• Performs review and approval for investigations, Corrective Action and Preventive Action, Quality Compliance Tracking System commitments, change requests, risks, Installation Qualification /Quality Operations/Process Qualifications, validation, Master Batch Records, etc.

• Performs Good Manufacturing Practice walkthrough inspections to ensure compliance with Good Manufacturing Practice and regulatory requirements. 

• Actively participates in site inspections/audits by facilitating discussions with inspectors/auditors, fulfilling requests for information and presenting to inspectors on required topics as Quality representative for the Integrated Process Team.  Supports the preparation of regulatory filings. 

• Responsible for the review and release of filled product for downstream packaging for both domestic and international markets. 

• Oversees preparation and submission of protocols for Center for Biologics Evaluation and Research and international markets.  Prepares to support regulatory filings. 

• Write, review, approve Standard Operating Procedures and other instructional documents for shop floor.

• Provides training to incoming personnel and ensures compliance with departmental procedures.

Education Minimum Requirement:

• Bachelor's degree in a science, engineering, or related areas of study.

Required Experience and Skills:

• At least 5 years of experience in a pharmaceutical, biotech, or related industry.

• Strong verbal and written communication skills.

• Strong understanding of Good Manufacturing Practice and regulatory requirements (domestic and international).

Preferred Experience and Skills:

• Proficiency in project planning and execution.

• Aseptic/Sterile processing experience preferred.

• Effectiveness and creativity in approaching and solving technical problems.

• Attention to detail, flexibility and an awareness of production and attendant quality control problems.

• Demonstrated leadership expertise working with cross-functional teams.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please