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Quality Control Analyst

2 months ago

Frederick, Maryland, United States Unicon Pharma Inc Full time
Job Overview

Position: Quality Control Analyst

Company: Unicon Pharma Inc

Work Environment: 100% onsite requirement

Work Schedule: Weekend shifts, evening to early morning

Contract Duration: 12 months, with potential for extension or full-time employment based on performance and organizational needs

Role Responsibilities:

The Quality Control Analyst will engage in various quality assurance tasks, which may include:

  • Reviewing, comprehending, and adhering to Standard Operating Procedures (SOPs) while ensuring compliance with current Good Manufacturing Practices (cGMP).
  • Creating new SOPs or updating existing documentation through document management systems.
  • Assisting in the assessment and approval of labeling, raw materials, intermediates, and finished products by promptly evaluating batch records, laboratory results, and other cGMP documentation.
  • Facilitating the issuance and reconciliation of GMP documentation.
  • Utilizing electronic systems and tools such as Trackwise, GQCLIMS, Pas-X, and SAP.
  • Demonstrating an understanding of fundamental scientific principles and cGMP.
  • Possessing basic knowledge of operational procedures and routine tasks within the core area.
  • Applying knowledge to repetitive, standardized tasks.
  • Employing basic analytical skills to formulate solutions to task-related challenges.
  • Seeking assistance for more complex issues as necessary.
  • Working under regular supervision while following established procedures.
  • Receiving detailed guidance for new assignments.
  • Prioritizing tasks as directed by others.
  • Having work reviewed for accuracy and thoroughness.
  • Contributing to departmental objectives through the quality and efficiency of standard operations.
  • Engaging primarily with department colleagues and supervisors, as well as occasionally with peers and supervisors from other internal departments.

Qualifications:

  • Education: Minimum of an Associate degree (or equivalent) in a science-related discipline.
  • Experience: 0-3 years in the biopharmaceutical or pharmaceutical sector.
  • Alternatively, a Bachelor's degree or 4 additional years of relevant work experience in lieu of a degree.
  • Or an Associate degree with 2 additional years of relevant work experience in lieu of a degree.