Principal Specialist, Quality Control (Data Review)

Cardinal Health•Indianapolis, IN

3d•$80,900 - $103,950•Onsite

About The Position

Quality Control is responsible for the analysis and inspection of products or processes for compliance with specifications and standards. This role serves as a technical leader within Quality Control chemistry, possessing in-depth knowledge of work processes and tools within their area and functioning as a Subject Matter Expert (SME). The position requires strong communication skills, attention to detail, organization, the ability to multi-task, and self-motivation. The individual will take actions to continually improve quality and safety, report errors promptly, and maintain accountability for regulatory requirements. They must also act calmly and patiently under pressure, maintaining integrity and composure while communicating with honesty and transparency.

Requirements

Bachelor’s degree or previous work experience in a similar role or related science field.
4-8 years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device).
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 strong technical writing skills.

Nice To Haves

Serves as a technical leader within Quality Control chemistry.
Exhibits Cardinal Health's high ethical standards and code of conduct.
Approaches work situations with 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.
Takes actions to continually improve quality and safety in daily work. Actively participates in improving work processes to meet and exceed expectations. Identifies opportunities for improvement based on process observations, outcome measures, and feedback.
Reports errors in a timely and appropriate manner. Takes initiative and is accountable for areas of responsibility meeting regulatory requirements including but not limited to maintaining required trainings as appropriate to position requirements.
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 member, regardless of background.

Responsibilities

Performs analysis of incoming materials, in-process, and product samples.
Serves as a technical mentor and training to personnel working in the chemistry department.
May lead and facilitate the qualification of applicable analytical instrumentation.
Executes method verification, validation, and/or transfer protocols, analytical equipment qualification protocols, or computer system validation test scripts.
Performs stability testing in alignment with stability protocols at the prescribed cadence.
Performs laboratory investigations, change controls, deviations, and corrective/preventative actions as needed.
Authors and optimizes SOPs, analytical testing forms, and other documents as necessary.
Serves as a subject matter expert (SME) for aspects of analytical testing, instrumentation, and/or processes.
Performs special projects or tasks as necessary based on skill set and/or development goals and business needs.
May assist the Supervisor and/or Manager by serving as a collaborator with multiple different departments to coordinate and facilitate analysis and special projects.
Champion Quality, cGMP compliance, and EHS/Radiation Safety practices.
Performs other job duties as assigned.