Senior Quality Specialist

The Senior Quality Specialist is an expert in their assigned area and has a strong understanding of current FDA, EU and ICH requirements. This role may specialize in various aspects of technical data and documentation evaluation and review, manufacturing operations, laboratory operations, investigations, and a variety of routine and non-routine tasks. This role ensures that all QA activities are in compliance with company SOPs, GMP/GLP standards and client requirements.

This role will coordinate with appropriate departments and/or cross-functional teams to ensure all applicable documents are reviewed and released within the specified timeframes. Ability to work within a dynamic and fast paced environment.

• Responsible for performing an independent quality evaluation and release of support documentation, materials, products, equipment, and facilities.
• Ensure all testing/manufacturing was performed per approved SOPs/methods/protocols and comply with specifications by critically evaluating the reported data and results for accuracy and compliance with other regulatory guidelines.
• Works independently on problems of basic to moderately complex scope in which analysis of situation or data requires a review of identifiable factors.
• Participates in department/client meetings, collaborates, and cooperates to achieve cross-functional improvements and business goals.
• Foster a culture of quality and continuous improvement focused on value to the customer.
• Ability to host and/or participate in internal, client and/or regulatory audits. Works with the site management in all areas to maintain a cGMP compliant facility in a constant state of inspection readiness.
• Exercises judgment within defined procedures and practices to determine appropriate action (root cause analysis tools, CAPA, etc.) for quality events.
• Good interpersonal skills and willing to ask questions about procedures and concepts.
• Participates in the development, implementation, and maintenance of procedures and policies to comply with FDA, EU, and ICH requirements applicable to site’s needs.
• Able to be trained and train/ mentor others.
• Effectively resolves quality issues and concerns in a timely manner.
• Effectively coordinates and organizes tasks to help drive the activities of others; while performing a variety of duties on schedule, with accuracy and competency.
• Creates strong and effective working relationships with Quality team, colleagues, and clients.

Knowledge
• Strong attention to detail, as well as time and resource management.
• Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to independently with minimal direction.
• Promote a safe environment for work.
• Communicate clearly and effectively both orally and in writing with internal and external clients.
• Working knowledge and understanding of LIMS and Empower.
• Skilled in MasterControl, Trackwise and/or other QMS software applications.
• Understanding of validation, production equipment, utilities, and/or drug development/manufacturing operations.
• Demonstrated theoretical understanding and providing effective evaluation of laboratory practices such as raw material, drug substance, drug product and medical device testing, compendia methods (e.g. USP/NF, EP, JP), and method validation/qualification/transfer, as required.

Skills / Abilities:
• Demonstrate the capability for continued upward growth and technical contributions.
• Strong analytical and problem-solving skills with proven ability to think strategically.
• Strong understanding of current FDA, EU and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry
• Effective team and interpersonal skills with the ability to work across numerous scientific and management disciplines.
• Excellent diplomatic, analytical, and communication skills – both verbal and written.
• Recognized as a technical resource in their assigned area.
• Strong Computer Skills
• Microsoft Suite, proficiency

• Related BA/BS, required.
• 4 -6 years of relevant experience in a CDMO and/or pharmaceutical environment, preferably in Quality Assurance.
• Experience in manufacturing operations, laboratory operations and/or QA, preferably in pharma or biotech.