San Francisco, CA 94102
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.
- 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.
- 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.
- Minimum Education: Bachelor’s degree
- Minimum 2 years Quality Assurance experience in a regulated environment