Senior Specialist, QC Documentation Review Chemist

What Quality Control contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

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

Primary Responsibilities

• Reports to Supervisor, Quality Control (Chemistry)
• Ensures timely and thorough review of Drug Substance, In-Process and Drug Product sample testing
• Reviews method verification, validation and/or transfer protocols
• Performs investigations, deviations, change controls and CAPAs, as necessary.
• Review stability testing in alignment with stability protocol(s) at the prescribed cadence.
• Demonstrates detail-oriented attention in all facets of responsibilities.
• Demonstrates knowledge of testing methods, product usage, and applicable regulations and standards.
• Aligns work priorities with immediate supervisor/management.
• May review analytical equipment qualification protocols or computer system validation including but not limited to, installation qualification, operational qualification, and performance qualification. These may be vendor-executed.
• Gain awareness of other departments at site. Seek to understand the functions of those departments and the points of interaction between Quality Control and your role.
• Exhibits Cardinal Health's high ethical standards and code of conduct.
• Performs special projects or tasks as necessary based on skill set and/or development goals and business needs.
• Required to have visual acuity and color perception
• Near-vision performance should be the equivalent of 20/20 with no impairment of color vision or correctable to 20/20 vision with the use of corrective lenses

Secondary Responsibilities

• Ensures timely and thorough inspections and analysis of incoming materials, Drug Substance, In-Process and Drug Product samples.
• Execute method verification, validation and/or transfer protocols.
• Perform stability testing in alignment with stability protocol(s) at the prescribed cadence.
• Performs visual assessment and analytical evaluation or test of products or processes.
• Adheres to established policies and procedures.
• Establishes test methodology.
• 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 be vendor-executed.

Qualifications

• Bachelors degree or previous work experience in a similar role or related field chemistry, or biology preferred.
• 3+ years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred.
• Has general knowledge and a high level of understanding of GDP documentation practices and requirements
• Has experience in authoring a variety of forms of documentation such as SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations.
• Must work well with others and understand how to be successful in a team environment.
• Must be detail oriented, organized, able to multitask, a self-starter, and self-motivated.
• Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.
• Demonstrated success in collaborating with people and working on a team.
• Strong communications skills.

Location
Onsite in Indianapolis, IN

Performance Expectations

• Demonstrates a commitment to the organizations mission, vision and values supporting organizational decisions and behaviors. Contributes to the development and implementation of systems and processes ensuring strategic goal attainment.
• Works as part of a team with others and shows respect and values diversity toward others.
• 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.
• 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.
  

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; 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.

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

• This role will primarily review Drug Substance, In-Process and Drug Product sample testing.
• This role will primarily review executed method verification, validation and/or transfer protocols.
• This role will primarily review stability testing in alignment with stability protocols at the prescribed cadence.
• This role will primarily review executed analytical equipment/instrument qualification protocols or computer system validation including but not limited to, installation qualification, operational qualification, and performance qualification. These may be vendor-executed.
• While the primary responsibility of this role is to review, this role will also be trained on all equipment/processes and will be asked to perform testing as necessary to support the business and QC Chemistry team.
• Exhibits Cardinal Health's high ethical standards and code of conduct.
• Approaches work situations with a positive and energizing style.
• Aligns work priorities with immediate supervisor/management.
• Gain awareness of other departments at site. Seek to understand the functions of those departments and the points of interaction between Quality Control and your role.
• Exhibit professional conduct and respect for others.

• Anticipated salary range: $67,500-$95,000
  Bonus eligible: No
  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 (Untracked)
  
• 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

Application window anticipated to close: 12/29/2024 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidates geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. 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.