Job Posting Title

Quality Assurance Manager

Trace-Ability Job Description

Trace-Ability Inc. develops and manufactures testing kits for radioactive tracers used in PET imaging. The tracer product release testing involves multiple analytical methods enabled on Trace-Ability’s proprietary automated platform.

As a quality assurance manager, the expectation is to support an important product development and commercial product programs. This position is expected to provide quality leadership in designing a robust quality system and implementation as well as hands on support. The quality program will entail utilization of cGMP and/or ISO quality system principles to deliver robust chemistry methods, testing kit manufacturing process and implementation of robust software and automated platform. The position will help the organization achieve ISO certification (9001). Additional role responsibility will be to work with CMO to execute the projects and provide quality oversight internally and externally.

Key responsibilities include:

• Enhance and manage current quality system: Apply fundamental principles and knowledge to drive enhancement and maintenance of robust quality system that meets the expectation of cGMP and/or ISO. Drive to achieve ISO 9001 certification.

• Continuous improvement: Evaluate existing quality system and how it is used to identify gaps or potential improvements to deliver and implement robust quality system.

• Support testing kit manufacturing: Review manufacturing and quality control testing to ensure the batches manufactured are of acceptable quality and meets the established requirement. Provide final disposition decision.

• Method/Technical transfer: Support method/technical transfers in alignment with existing quality and technical requirement.

• CDMO/CMO quality management: Manage the site for manufacturing, testing and release activities to be compliant with established quality system and expectation. Provide the final release and disposition of the batches manufactured.

• Serve as the quality system Subject Matter Expert (SME) in operations for internal and external customers and for the product life cycle management activities.

Daily duties will include review and approve procedures, batch records, protocol/reports. Review and release/disposition batches. Assess and mentor organization and staff on quality. Maintain and manage quality system and supporting required activities.

Basic Qualifications

• Doctorate degree

OR

• Master’s degree & 2 years of directly related experience

OR

• Bachelor’s degree & 3 years of directly related experience

OR

• Associate’s degree & 5 years of directly related experience

OR

• High school diploma / GED & 10 years of directly related experience

Preferred Qualifications

• 3 years experience within the pharmaceutical/biotechnology industry.

• Thorough knowledge and experience of GxP, ICH, and ISO to be able to manage quality system.

• Experience in statistical analysis and/or method/tech transfer experience.

• Ability to participate in teams and work effectively in a small company environment and where hands on work is necessary.

• Ability to understand fundamental requirements of regulated industry and able to prioritize critical activities. Ability to quickly grasp knowledge and learn to adapt and implement the learning effectively and efficiently.

• Experience with technical documentation, batch records, GMP documentation and regulatory filings.

• Experience in supporting cross-functional teams, strong oral and written communication skills to audience with various technical backgrounds.

• Initiative, attention to detail, and strong ability to prioritize daily work based on changing business requirements.

• Must possess good computational skills, good organizational and multi-tasking skills.

• Ability to influence cross functional groups will be important features of this job.

Country (State/Region)

United States - California

Career Category

Operations

Location (City)

Van Nuys

Job Type: Full-time

Pay: $80,000.00 - $100,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person