Quality Assurance Associate (Hybrid, 2 days p/w Remote)

Hamlyn Williams is partnered with a Series B-funded clinical-stage biotech organization, looking to grow their QA function after recent funding and extremely positive developments with their lead asset in the clinic.

As QA Associate, you will support the routine monitoring and maintenance activities associated with the QMS in accordance with internal procedures, and US FDA guidelines across GCP, GMP, and GLP. This role is hybrid from LA and is targeting a base salary between $100,000 and $115,000 per year, before bonus and benefits.

Additional Responsibilities are as follows:

• Assist QA team with development of presentation materials, communication tools, etc.
• Track and coordinate periodic review of written procedures, Quality/Service level Agreements, and supplier re-qualification cycles.
• Assist QA team with scheduling, travel, and communication of quality audits
• Liaise with suppliers and outside vendors effectively
• Assist new staff with onboarding and day to day activities
• Track and trend Quality metrics

Qualifications:

• 3 years of relevant experience in Quality Assurance support within a bio/pharmaceutical or CRO preferred
• College degree required
• Excellent administrative skills
• Excellent communication skills, both internally with cross-functional groups and also with outside vendors
• Ability to take direction, and work under pressure in a fast-paced biotech environment
• Comfort with electronic software and applications. Advanced skills in electronic business applications including WORD, PowerPoint, Excel, Adobe, Visio, SmartSheet, Sharepoint, BOX, etc.Familiarity and comfort with technical terminology, data collection/representation, graphic displays, basic mathematical/statistical concepts