Supervisor, Quality Control (QA-QC)

Cardinal Health•Indianapolis, IN

21h•Onsite

About The Position

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 Supervisor, Quality Control (QA-QC) contributes to Cardinal Health Quality Control is responsible for the analysis and inspection of products or processes for compliance with specifications and standards. Demonstrates detail-oriented attention in all facets of responsibilities. Performs analytical evaluation of products or processes. Has knowledge of testing methods, product usage, and applicable regulations and standards. Established test methodology and adheres to established policies and procedures. Provides technical guidance and training to others on SOPs and quality guidelines. What is expected of you and others at this level Exhibits Cardinal Health's high ethical standards and code of conduct. Applies expertise to improve effectiveness and solves standard and non-standard problems, providing guidance to employees. Sets priorities for the shift to ensure task completion, coordinates work activities with other shifts (1st/2nd/Weekend). Assists work team in the achievement of goals/commitments, achieving own goals/commitments regardless of obstacles. Has in-depth knowledge of work processes and tools within own area and can function as a subject matter expert (SME). Partners with leadership to make decisions, often difficult and/or unpopular, that impact the work of subordinates within job family; influences subordinates to support decision by presenting rationale/business case. Role models Cardinal Health's high ethical standards and code of conduct. Recognizes development needs and capability gaps in own area and arranges specific projects/assignments to address needs. Provides direction in discussing and creating development plans. Provides input into succession planning process for own work area. Aligns individual goals for self and others with work area/functional goals. Works within budgetary/ financial objectives set by manager, applying knowledge of profit drivers to work processes within own area. Builds confidence and respect of others through a positive and energizing style. Is aware of internal/external business issues and adapts work priorities in own area. Works with customers to anticipate and interpret customer needs and business challenges by identifying quality and service-oriented customer solutions and shares key learnings with others. Encourages subordinates to strive for operational excellence by continually challenging old methods or ways of thinking and taking responsible risks to maximize results; serves as a role model in innovative thinking and in focusing on quality within work. Effectively solicits and explains difficult concepts and persuades others to adopt a point of view; states own point of view. Actively builds relationships across functions/businesses that bring value to the company, encouraging the participation and perspectives of all team members, regardless of background; mentors and empowers others to achieve success Effectively listens to and explains difficult issues to reach shared understanding and build alignment Responsible for being a culture champion by participating in the development, monitoring and sustainment of the culture that is an integral part of the Indy manufacturing sites philosophy and vision. Is responsible for embracing and demonstrating the culture of energy, passion and positive atmosphere while delivering superb customer service.

Requirements

Bachelor’s degree in chemistry or related science field.
Experience in radiochemistry, quality control or quality assurance preferred.
8+ years of relevant work experience with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device).
Must have experience with equipment qualification, software validation, test method validation, and/or process validation.
Has experience in authoring a variety of documentation such as SOPs, Change Controls, CAPAs, Deviations (Nonconformance), and Laboratory Investigations.
Must understand the validation and technology transfer process and have experience with reviewing procedures/reports and laboratory tests.
Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.

Responsibilities

Coordinates and supervises the daily review (Technical and GDP) of Analytical documentation in the analysis of raw materials, drug substance, in-process and drug product testing.
Is a quality lead for the QC Chemistry team
Identifies quality events and works with QA/QC management to ensure each event is handled in accordance with site procedures and regulatory requirements
Oversees scientists that review analytical documentation for technical and GDP completeness/correctness
Analytical Documentation includes but is not limited to the following: Laboratory Testing Forms (Release, Protocol, or Stability), Protocols, Method Validation/Verification/Transfer(s), Instrument Qualification, and Incoming Material Inspections
Interpret results and documents findings in accordance with SOPs and regulatory requirements.
Trains, assesses and coaches team documentation review, techniques and career development as needed.
Performs technical review of investigations, deviations and CAPAs.
Oversees and authors written procedures and other documents, including amendments.
Ensures results are consistent with acceptable test parameters and reports abnormal findings from Analytical tests to the Manager of Quality Control (Chemistry).
Ensures employees operate within guidelines and the associated records are reviewed in accordance with site specific procedures and documents are provided to the QA team in a timely manner to ensure COA is generated and product release is OTIF (On Time In Full)
Assists in the recommendation for approval or rejection of starting materials, intermediate, and finished products.
Develops and applies practices which will enable the laboratory to meet and exceed desired customer and regulatory standards in a cost-effective fashion.
Assists in and/or conduct all laboratory investigations of discrepancies to resolve problems and works with other members of management to ensure corrective action or preventative actions are implemented in a timely manner.
Remains aware of developments in chemistry by reading current technical literature and attending technical meetings.
Makes recommendations to other members of management to improve the performance of the laboratories.
Executes or participates in internal/external laboratory quality audits, as directed by management to ensure that all associated records are evaluated.
Assists in training efforts and development of laboratory personnel.
Works closely with operations regarding the interpretation and implementation of any elements of the Quality Management System, to resolve differences and ultimately ensure the system is understood and applied uniformly.
Ensures all work is carried out in a manner demonstrating support for and adherence to the Company’s Safety Policy and Procedures, Quality Policy and Procedures, Ethics Policy, Environmental management System, Vision and Strategy, and to exercise good judgement, common sense, and diplomacy in doing so.
Produces and reviews personal development plans for team members, identifying and providing appropriate training.
Oversees the execution of all qualification protocols and ensure proper IOQ task completion.
Ensures any Safey, Quality, or Site actions are completed effectively and in a timely manner and that the escalation process exists to raise quality issued to the appropriate levels of management.
Performs other job duties as assigned.

Benefits

Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs