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Quality Assurance Specialist

2 months ago

Orange, California, United States BioPhase Solutions Full time
Job Description

BioPhase Solutions is seeking a highly skilled Quality Assurance Specialist to join our team in the contract manufacturing industry.

Key Responsibilities:
  • Document Review: Conduct thorough reviews of batch records, test results, and technical documentation to ensure compliance with cGMP regulations and SOPs.
  • Collaboration: Work closely with operations management to review and approve SOPs, protocols, reports, equipment qualifications, and calibrations.
  • Regulatory Compliance: Provide assistance during cGMP compliance inspections and coordinate the retrieval of quality documents and records.
  • Supplier Assurance: Support the execution of the supplier assurance program at the site.
  • Product Release: Review and approve raw materials and final product for release.
  • Counseling: Provide cGMP compliance guidance and advice as needed.
  • Deviation Management: Review and approve deviations.
  • Quality Metrics: Support QA management in gathering data for tracking quality metrics.
  • Workplace Safety: Maintain a clean and organized workspace and adhere to safe work practices.
Requirements:
  • Experience: 2-3 years of industry-related work experience.
  • Education: Bachelor's degree or equivalent in a scientific discipline.
  • Regulatory Knowledge: Proficient experience and knowledge of cGMP regulations, FDA, and ICH guidelines.
  • Technical Skills: Proficient experience and knowledge of USP, Pharm. Eur., and other applicable standards.
  • Problem-Solving: Proficient knowledge of root cause investigation and problem-solving techniques.
  • Software Proficiency: Proficient experience and knowledge of LIMS and electronic documentation systems.
  • Communication: Excellent communication and problem-solving skills.