Source Medical, LLC.

Source Medical, LLC.

Principal Specialist, Quality Control Chemistry Testing (Weekend Shift)

IN-Indianapolis-Theranostics Commercial · Principal

Sponsorship not specified$81k-$116kDetected 1 day ago
ExcelGMPFDA RegulatoryMedical DevicesCommunicationWritingMicrosoft Office

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26Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds (Level II)66
Fits your clock70

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About the role

  • What hours does a Principal Specialist, Quality Control (Chemistry) (Weekend shift) at Cardinal Health expect?
  • This shift is expected to work from 12:00 PM - 12:00 AM, Friday - Sunday.
  • Actively participates in improving work processes to meet and exceed expectations.

Responsibilities

  • Performs analysis of incoming materials, in-process, and product samples.
  • May lead and facilitate the qualification of applicable analytical instrumentation.
  • Performs stability testing in alignment with stability protocols at the prescribed cadence.
  • Performs laboratory investigations, change controls, deviations, and corrective/preventative actions as needed.
  • Authors and optimizes SOPs, analytical testing forms, and other documents as necessary.
  • Performs special projects or tasks as necessary based on skill set and/or development goals and business needs.
  • Performs other job duties as assigned.

Requirements

  • Has experience in authoring a variety of forms of documentation such as SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations.
  • 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
  • 5+ years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device).
  • Proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.
  • Physical/ Mental Requirements
  • While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand
  • use hands to finger, handle or feel
  • and reach with hands and arms
  • 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.

Nice to have

  • Bachelor's degree or previous work experience in a similar role or related science field preferred

Compensation

  • $80,900 - $115,500

Benefits

  • Medical, dental and vision coverage
  • Paid time off plan
  • Health savings account (HSA)
  • Flexible spending accounts (FSAs)
  • Short- and long-term disability coverage
  • Paid parental leave
  • Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

Company info

  • Join a growing, global company genuinely committed to making a difference for our customers and communities.
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