On site
Alentown, PA 18103
Posted 1 month ago
US Specialty Formulations, a rapidly growing pharmaceutical manufacturer centrally located in the Lehigh Valley, Pennsylvania, has an opportunity for an entry level quality assurance associate.  The QA associate will support the continued development and implementation of the quality management system at US Specialty Formulations.  The  candidate must be detail oriented and effective in verbal and written communication. The QA associate will report directly to the Executive Director of Quality.
Primary Duties and Responsibilities:
  • Assist in the collection, documentation, review, and reporting of various quality data.
  • Scan, organize, and maintain an electronic file of approved materials and equipment used in manufacturing and testing.
  • Organize and maintain equipment calibration schedule and assign of equipment calibration events.
  • Compile, organize, and review batch production records, raw material documentation, and environmental monitoring results.
  • Review laboratory records and log sheets for completeness and good documentation.
  • Ensure conformance of third-party laboratory testing for finished product specifications.
  • Assist the Executive Director of Quality in conducting internal, external, and regulatory audits and inspections. As required, support the drafting of responses to audit findings.
  • Maintain log of active change controls, non-conformance investigations, and CAPAs and assign actions to specific personnel.
  • Perform clerical tasks as assigned by the Quality Director.
Minimum Knowledge, Skills, and Abilities:
  • Must be detail oriented, organized, and thorough at maintaining schedules.
  • Capable of prioritizing multiple responsibilities and projects.
  • Proficient writing abilities.
  • Knowledge of quality systems methods and practices (CAPA, Root Cause Analysis, Investigations, etc.)
  • Strong knowledge in Microsoft Word, PowerPoint, and Excel
Background and Experience:
  • Associate or Bachelor’s degree, preferably in chemistry or life sciences (e.g. biology, microbiology, biochemistry, etc.)
  • 1-3 years of related experience in a position with similar skills and duties
  • 401(k)
  • Flexible schedule
  • Health insurance
  • Paid time off
  • Monday to Friday
Supplemental pay types:
  • Bonus pay
Ability to commute/relocate:
  • Allentown, PA 18103: Reliably commute or planning to relocate before starting work (Required)

Job Features

Job Category

Quality Assurance

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