Supervisor, Quality Control (QC Chemistry)

in Indianapolis, IN

Supervisor, Quality Control (QC Chemistry) Job

Job Description Job Attributes+

  • Job ID

    cdbbef23-b17f-4edb-97e4-08a0b2eb79c9

  • Req #

    20089302

  • Job Location

    4343 W 62nd Street
    Indianapolis, IN 46268, US

  • Job Category

    Quality

  • Job Type

    Regular

  • Schedule

    Full time

What Quality Control contributes to Cardinal Health

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

  • Reports to the Manager, Quality Control
  • Quality control is responsible for the analysis or inspection of products or processes for compliance against specifications and standards.
  • Demonstrates detailed oriented attention in all facets of responsibilities.
  • Performs analytical evaluation or test of products or processes.
  • Demonstrates knowledge of testing methods, product usage, and applicable regulations and standards.
  • Adheres to established policies and procedures.
  • Establishes test methodology.
  • Provides technical guidance and training to others on analytical methods, SOPs and quality guidelines.

    Work Environment

  • The primary work environment consists of a professional office environment within a radiopharmaceutical manufacturing facility 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.

    Accountabilities

  • Coordinates and supervises the daily activities of chemists or business support staff in the analysis of raw materials, drug substance, in-process and drug product testing.
  • Oversees chemists and contractors who operate analytical equipment, perform analytical tests, interpret results and documents findings in accordance with SOPs and regulatory requirements.
Trains, assesses and coaches team in analytical methods, laboratory procedures, techniques and career development as needed.Leads and facilitates the qualification of analytical instrumentation.Performs technical review of investigations, deviations and CAPAs.Oversees and authors written analytical methods, procedures and other documents as necessary.Leads team members through the analytical method transfer process.Coordinates and supervises the daily activities of chemists or business support staff in the analysis of raw materials, drug substance, in-process and drug product testing.Leads and facilitates the development and validation of new analytical methods as needed in alignment with ICH requirements.Leads and facilitates the verification of compendia analytical methods.Assists Manager of Quality Control with special projects as needed.Designs and leads drug product stability studies.Ensures results are consistent with acceptable test parameters and reports abnormal findings from analytical tests to the Manager of Quality Control.Ensures employees operate within guidelines.Performs special projects or tasks as necessary based on skill set and/or development goals and business needs. Performs other job duties as assigned.

Qualifications

A Covid-19 vaccination is required in order to be employed in this position. This includes either: 2 doses of the Moderna or Pfizer vaccine OR1 dose of the Johnson & Johnson vaccineBachelor’s degree in physical or life science, chemistry, biochemistry or equivalent work experience preferred6+ years experience of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device)strongly preferredExperience in radiochemistry, nuclear pharmacy, or health physics preferred.Experience with equipment qualification, test method validation and verification, and/or process validation. Must understand the Technology Transfer process and have experience with writing protocols, procedures, summary reports as well as familiarity with method transfer protocol execution.Have technical writing experience with documents such as standard operation procedures (SOPs), analytical methods, laboratory investigations and deviation investigations and creation of CAPAs and change control plans.Must work well with others and understand how to be successful in a team environment.Demonstrated success in managing people and leading a team.Strong communication skills.Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills. Must be detail oriented, organized, able to multi-task, a self-starter, and self-motivated.Travel is required 10%.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; talk or hear; and taste or smell. 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.

What is expected of you and others at this level

Works closely with and takes direction fromthe Manager, Quality Control Chemistry.Coordinates and supervises the daily activities of professionals, business support, or technical staff in an assigned area.Applies expertise to improve effectiveness and solves standard and non-standard problems, provide guidance to employees in own area.Sets priorities for the team to ensure task completion; coordinates work activities with other. Assists work team in the achievement of goals/ commitments; achieves own goals/commitments regardless of obstacles.Has in-depth knowledge of work processes and tools within own area, and can function as Subject Matter Expert (SME) for processes, tools, and equipment.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 successEffectively listens to and explains difficult issues to reach shared understanding and build alignmentResponsible 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. The incumbent is responsible for embracing and demonstrating the culture of energy, passion and positive atmosphere while delivering superb customer service.

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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