• Job Description

  Req#: 26-07758
  
  Our Client, a Aesthetics and skincare solutions \company, is looking for a Compliance Specialist, Analytical Development III for their Newark, CA (onsite) location.
  
  Responsibilities:
  • Work closely with the CMC team to manage and coordinate analytical activities
  • Manage early and/or late phase drug substance and drug product analytical activities at contract testing laboratories (method development, method qualifications/validations, method transfers, analytical investigations support)
  • Execute technical analytical methodologies to support development and validation of test methods.
  • Author and review raw data (e.g. stability data packages and ad hoc testing), analytical methods, protocols, reports, and other technical documents, including instrument qualification and change control.
  • Assist in authoring and reviewing various regulatory submission and interaction documents
  • Assist in the developing, authoring, and/or reviewing standard operating procedures
  • Manage reference materials and reference standards inventory and (re)qualification testing
  • Manage vendor maintenance and calibration for AD-owned equipment, instruments, and systems
  • Ensure adherence to GMPs, GLPs, GCPs and GDPs where required.
  
  Requirements:
  • Experience in drafting protocols, methods, reports, and/or procedures.
  • Experience in performing change control, deviation, laboratory investigation, and/or other quality records.
  • Be able to communicate technically and strategically across technical and operational activities and work collaboratively to ensure successful execution.
  • Strong written and verbal communication skills.
  • Working knowledge of statistics; R, Python, or other statistical tools preferred.
  • Ability to work on multiple projects simultaneously, demonstrating organizational and problem-solving skills.
  • Self-motivated, proactive and driven individual with an interest in experimental design and development.
  • Demonstrated experience in managing outsourced analytical activities
  • Demonstrated experience in QC data review of release and stability data packages
  • Experience in Liquid Chromatography and/or Immunoassays is highly desired.
  • Bachelor’s degree in biological sciences or related field with 4+ years of progressive experience in the biotechnology or pharmaceutical industry.
  • 3+ years of experience in a regulated/GMP environment.
  • 2+ years of experience in a quality function (QC or QA organization)
  
  Why Should You Apply?
  • Health Benefits
  • Referral Program
  • Excellent growth and advancement opportunities
  
  As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.
  
  
  

• About the company

  ICONMA is a nationwide consulting firm with corporate headquarters in Troy, MI, providing Professional Staffing and Project Based Services and Solutions for Fortune 1000 clients in a broad range of industries. Core Industries served include: Biotech/Ph...

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