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Supervisor, Quality Control Chemistry

Supervisor, Quality Control Chemistry

Cardinal HealthIndianapolis, IN, US
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Supervisor, Quality Control (Chemistry)

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.

Quality Control is responsible for the analysis and inspection of products or processes for compliance with specifications and standards.

Responsibilities include :

  • Supervising the daily activities of Chemists or business support staff in the analysis of raw materials, drug substance, in-process and drug product testing.
  • Acting as a quality lead for the QC Chemistry team while limited management presence is available on 2nd shift.
  • Overseeing chemists and contractors who operate analytical equipment, perform analytical tests, interpret results and documents findings in accordance with SOPs and regulatory requirements.
  • Training, assessing and coaching team in laboratory procedures, techniques and career development as needed.
  • Leading and facilitating the qualification of analytical instrumentation, verification of compendia analytical methods, stability studies.
  • Performing technical review of investigations, deviations and CAPAs.
  • Overseeing and authoring written procedures and other documents, including amendments.
  • Leading team members through the analytical method transfer process.
  • Ensuring results are consistent with acceptable test parameters and reporting abnormal findings from Analytical tests to the Manager of Quality Control (Chemistry).
  • Ensuring employees operate within guidelines, all necessary testing is carried out, and the associated records are evaluated.
  • Assisting in the recommendation for approval or rejection of starting materials, intermediate, and finished products.
  • Developing and applying practices which will enable the laboratory to meet and exceed desired customer and regulatory standards in a cost-effective fashion.
  • Assisting in and / or conducting all laboratory investigations of discrepancies to resolve problems and working with other members of management to ensure corrective action or preventative actions are implemented in a timely manner.
  • Remaining aware of developments in chemistry by reading current technical literature and attending technical meetings.
  • Making recommendations to other members of management to improve the performance of the laboratories.
  • Ensuring proper laboratory hygiene and monitoring the storage conditions for materials and products used in the labs.
  • Executing or participating in internal / external laboratory quality audits, as directed by management to ensure that all associated records are evaluated.
  • Assisting in training efforts and development of laboratory personnel.
  • Working closely with operations regarding the interpretation and implementation of any elements that the system of the Quality Management System, to resolve differences and ultimately ensure the system is understood and applied uniformly.
  • Ensuring 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.
  • Producing and reviewing personal development plans for team members, identifying and providing appropriate training.
  • Playing a key role in the creation of analytical equipment qualification protocols and timely delivery of analytical equipment in the various quality control rooms. Overseeing the execution of all qualification protocols and ensure proper IOQ task completion.
  • Ensuring any Safety, Quality, or Site actions are completed effectively and in a timely manner and that the escalation process exists to raise quality issues to the appropriate levels of management.
  • Performing other job duties as assigned.

Schedule :

  • 2nd Shift - Anticipated 3 : 00 pm - 12 : 00 am
  • Potential to work 1st shift, to cover PTO of other analysts
  • Initial training for this role will be provided on 1st shift.

    • Qualifications include :

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

    • Physical / Mental Requirements :

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
  • While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; balance; stoop, kneel, crouch or crawl. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.

    • Work Environment :

  • The primary work environment consists of a professional office environment within a radiopharmaceutical manufacturing facility, the materials warehouse as well as the laboratory setting.
  • The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory groups. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he / she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.

    • 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 team to ensure task completion, coordinates work activities with 1st shift and facility / department goals.
  • 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 to anticipate 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 site philosophy and vision. Is responsible for embracing and demonstrating the culture of energy, passion and positive atmosphere while delivering superb customer service.

    • Anticipated salary range : $76,700 - $113,800

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