Quality Control Chemist II: Expert Analysis & Method Transfer

Cardinal Health, Inc.; Legendary Hills (IN); On-site; USD 69,000 - 88,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

Paid time off

Job summary

Cardinal Health, Inc. is seeking a Quality Control professional to lead inspections and analyses of materials, drug substances, in-process and drug product samples. You will execute verification, validation and transfer protocols and perform stability testing in line with established cadences.

The role requires strong technical writing, GDP knowledge, and the ability to train others on SOPs and instruments while adhering to Cardinal Health's high ethical standards and regulatory requirements.

Qualifications

• Bachelor’s degree or previous work experience in a similar role or related field chemistry, or biology preferred.
• Has general knowledge of GDP documentation practices and requirements
• Has experience in authoring forms of documentation such as SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations.
• Must be detail oriented, organized, multitask, 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.

Responsibilities

• Reports to Supervisor, Quality Control (Chemistry)
• Ensures timely and thorough inspections and analysis of incoming materials, Drug Substance, In-Process and Drug Product samples.
• Performs investigations, deviations, change controls and CAPAs.
• Execute method verification, validation and/or transfer protocols.
• Perform stability testing in alignment with stability protocol(s) at the prescribed cadence.
• Authors standard operating procedures, analytical method worksheets, forms and other documents as necessary and applicable.
• Demonstrates detail-oriented attention in all facets of responsibilities.
• Performs visual assessment and 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.
• May train others on SOPs, PROTOCOLs, instruments and quality guidelines.
• May execute analytical equipment qualification protocols or computer system validation test scripts.
• 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.
• 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.
• Performs other job duties as assigned.
• 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
• 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.
• This role will perform analysis of Incoming Materials, Drug Substance, In-Process and Drug Product samples.
• This role will execute method verification, validation and/or transfer protocols.
• This position will perform stability testing in alignment with stability protocol(s) at the prescribed cadence.
• This position may execute analytical equipment qualification protocols or computer system validation test scripts.
• 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.

Skills

Attention to detail

Team collaboration

Technical writing

Education

Bachelor’s degree or related field

2+ years FDA regulated industry experience

Tools

Microsoft Word

Microsoft Excel

Job description

Cardinal Health, Inc. is seeking a Quality Control professional to lead inspections and analyses of materials, drug substances, in-process and drug product samples. You will execute verification, validation and transfer protocols and perform stability testing in line with established cadences.

The role requires strong technical writing, GDP knowledge, and the ability to train others on SOPs and instruments while adhering to Cardinal Health's high ethical standards and regulatory requirements.