Principal Specialist, Quality Control (Chemistry) – Incoming Materials

About this role

At Cardinal Health, we’re developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities.

What a Principal Specialist, Quality Control (Chemistry) – Incoming Materials contributes to Cardinal Health Quality Control is responsible for the analysis and inspection of products or processes for compliance with specifications and standards. • Reports to Supervisor, Quality Control Incoming Materials (Chemistry).

• Demonstrates detail-oriented attention in all facets of responsibilities.

• Performs visual inspection, dimensional measurement, physical characterization and analytical evaluation or test of products and processes.

• Demonstrates knowledge of testing methods, product usage, and applicable regulations and standards.

• Adheres to established policies and procedures.

• Establishes test methodology and may contribute to the development of policies and procedures.

• Serves as a technical mentor and trainer to others on SOPs and quality guidelines.

What is expected of you and others at this level • Serves as a technical lead of Quality Control regarding incoming GMP material inspection and physical characterization testing and performs investigations of non-conforming materials as necessary.

• Serves as a lead collaborator on behalf of Quality Control with multiple different Cardinal Health departments to coordinate and facilitate the packaging and shipment of materials to external service vendors for testing that cannot be performed on site.

• Has in-depth knowledge of work processes and tools within own area and can function as a Subject Matter Expert (SME) for processes, tools, and equipment.

• Exhibits Cardinal Health's high ethical standards and code of conduct.

• Serves as the liaison between Quality Control and external service vendors and is responsible for scheduling testing and timely receipt of reported results from external service vendors for the purpose of releasing incoming GMP material for use in the manufacture of product(s).

• Builds confidence and respect of others through a positive and energizing style.

• Possesses in-depth knowledge of work processes and tools within own area and can function as a Subject Matter Expert (SME) for processes, tools, and equipment.

• Gain awareness of other departments at site. Seek to understand the functions of those departments and the points of interaction between QC and your role. 

• Exhibit professional conduct, respect for others, and understands how to be successful in a team environment.

• Is detail oriented, organized, had the ability to multi-task, and is self-motivated. Is aware of internal/external business issues and adapts work priorities in own area.

• Demonstrates strong communication skills. Effectively listens to and explains difficult issues to reach shared understanding and build alignment.

• Has the ability to act calmly and patiently when working under pressure and/conditions of stress. Maintains integrity, composure, communicates with honesty, transparency, clarity and promotes alternative perspectives.

• Actively builds relationships across functions/businesses that bring value to the company, encouraging the participation and perspectives of all team members, regardless of background.

Responsibilities • Works with multiple departments to ensure timely and thorough inspections and analysis of incoming, raw and GMP printed materials.

• Creates specifications by thoroughly investigating incoming materials and associated requirements: Certificates, storage condition, expiration date, sampling quantity, sampling requirements, etc.

• Creates inspection plans, material inspection characteristics, and assigns them to materials in SAP.

• Provide material to the Warehouse teams for shipment to outsource testing facilities.

• Work directly with outsource testing labs to ensure timely completion of testing.

• Serve as a technical mentor and trainer to personnel working in the QC Incoming Materials section or on incoming material inspections.

• May lead and facilitate the qualification of applicable analytical instrumentation.

• Performs investigations, deviations, change controls, and CAPAs.

• Serves as a Subject Matter Expert (SME) for the inspection and analysis of incoming, raw, and GMP printed materials.

• Authors and optimizes standard operating procedures (SOPs), laboratory testing forms, and other documents as necessary and applicable.

• Performs special projects or tasks as necessary based on skill set and/or developmental goals and business needs.

• Ensures timely and thorough inspections and analysis of Drug Substance, In-Process, and Drug Product samples.

• Executes method verification, validation, and/or transfer protocols.

• Performs stability testing in alignment with stability protocol(s) at the prescribed cadence.

• Performs visual assessment and analytical evaluation or test of products/processes.

• Established test methodology and adheres to established policies and procedures.

• May train others on SOPs, Protocols, instruments, and quality guidelines.

• May execute analytical equipment qualification protocols or computer system validation including but not limited to, installation qualification, operational qualification, and performance qualification (These may also be vendor-executed).

• Performs other job duties as assigned.

Qualifications • Bachelor’s degree or previous work experience in a similar role or related field, Chemistry or Biology preferred.

• 4+ years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated

industry (Pharmaceutical or Medical Device) with SAP experience preferred. • Has experience in authoring a variety of forms of documentation such as SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations.

• Proficient in Microsoft Word and Microsoft Excel and possess st

Similar jobs

• Manager, Quality Control Chemistry — BeiGene · Remote
• Senior Manager, Quality Control — Gilead Sciences · La Verne, California, United States
• Quality Control Chemist — Brenntag · Southgate, California, United States
• Senior Specialist, QC Analytical — Bristol Myers Squibb · Summit West, NJ
• Senior Director, Quality Control & Analytical Development — Loyal36 · Remote
• Sr. Incoming Quality Inspector — Analog Devices · MA, Chelmsford, Alpha
• Senior Engineer, Materials Quality Engineering — Entegris · Colorado Springs, CO
• Senior Engineer, Materials Quality Engineering — Entegris · San Luis Obispo, CA