QA Associate

Job Title: QA Associate

Job Number: 33255

Location: , CA

Job Description

We are looking for an individual who is self-driven and can work well in a team. This will involve tasks such as scrutinizing batch records, investigating deviations, issuing labels, and managing company-wide controlled documentation, training, and facility support systems, including tracking, distributing, and archiving them in accordance with GLP/GCP/GMP regulations.

Responsibilities

• Write and/or review policies, standards, procedures, and work instructions to document Quality documentation processes and practices.
• Support supplier and material management, including ordering, incoming receipt, and record-keeping.
• Coordinate, track, and archive controlled records (i.e., batch/test records, logbooks, validation documents, labels, reports, forms, etc.) for change controls, deviations, CAPAs, audits, training, equipment calibration, and preventative maintenance.
• Process controlled documentation through the GxP (GLP / GCP / GMP) documentation system, including but not limited to word processing, tracking, issuing, distributing, and archiving, utilizing manual or an electronic document management system.
• Conduct or coordinate deviation investigations, corrective and preventative actions (CAPA), change controls, company-wide training, and internal audits. Write associated reports.
• Collaborate on the development/improvement and implementation of material, facility, and quality management systems.
• Support clinical product manufacturing by reviewing batch records, printing labels, packaging products, and coordinating shipping.
• Manage inventory databases, ensuring accurate and timely updating of lot numbers and quantities.
• Perform other assigned duties as required.

Required Skills

• Bachelor’s Degree and 2+ years of experience in a cGMP environment
• Comfortable working in a fast-paced and dynamic environment 
• Knowledge of standard processes involved in document control and experience in an FDA regulated environment
• Aseptic Processing experience is a plus. Additionally, strong computer skills in MS Word, Excel, Visio, Access; Adobe suite; and database systems. 
• Precise attention to detail and excellent record keeping skills. Familiarity with Quality Systems and records management in a cGMP environment is also important. 
• Must have strong communication and problem-solving skills, be results-oriented with dedication to compliance and customer service, and exhibit strong initiative and follow-through.

Salary range: $65,000-85,000K annually

Benefits:
Health Insurance (medical, dental, vision)
Life Insurance
Short- and Long-Term Disability
401(k)
Paid Time Off