QA Associate

5/18/20

San Francisco, CA 94102

985

FullTimeRegular

Our client, a pharmaceutical company is looking for a successful Quality Assurance candidate who will be responsible for coordinating and directing quality assurance programs and reviewing, preparation/maintenance of SOPs, calibration and other controlled document to ensure accuracy, completeness, and adherence to establishment standards by performing the following duties.

Responsibilities Include:

  • Ensures compliance with cGMP, Company SOPs and Regulatory requirements during all phase of operations.
  • Provide training on quality assurance and Regulatory compliance topics.
  • Oversight of the vendor management program.
  • Maintains the records for calibration on process equipment.
  • Maintains and oversees documentation control of all regulated documents using Quality Management System.
  • Prepares and maintains record for change control, planned or unplanned deviation, customer complaint investigation report, mock recall, annual GMP training.
  • Perform line clearance, issue batch records prior to manufacturing.
  • Disposition raw materials for use in pharmaceutical goods.
  • Updates and maintains records including training, SOPs, Validation and Calibration documentation.
  • Assesses incoming complaints and escalate issues that require Management immediate attention.
  • Participates in internal and external audits.

Skills:

  • Knowledge of Federal and State Regulations
  • Knowledge of pharmaceutical manufacturing practices, validation methods, inspection and testing methodologies
  • Proficient computer skills, (MS Word, MS Excel and Power Point) are essential

Abilities and Personal Characteristics:

  • This is a highly collaborative environment where willingness and ability to communicate and work flexibly within a team is essesntial
  • Commitment to safety
  • Strong interpersonal skills
  • Proven ability and success at working independently
  • Proven ability to multitask and plan
  • Strong attention to detail and oral and written communication skills.
  • Strong problem identification/analysis and sense of accountability, responsibility, and ownership of projects and tasks.

Qualifications:

  • Minimum Education: Bachelor’s degree
  • Minimum 2 years Quality Assurance experience in a regulated environment

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