Senior Associate, Quality Assurance

Job Description

Job Description

Title : Senior Associate, Quality Assurance

Location : Bothell, WA

Duration : 12+ Months

The Quality Assurance team is seeking a highly motivated and detail-oriented Quality Assurance Senior Associate to join our team at the Client's Manufacturing Facility, LyFE in Bothell WA. This individual will perform routine Quality Assurance tasks including but not limited to batch record review, raw material disposition, deviation investigation, CAPA, and change control approval, and other Quality Operations functions. This role requires working either a Wednesday through Saturday shift or a Sunday through Wednesday shift, 10 hours per day, and is an onsite role with no remote work option.

KEY RESPONSIBILITIES :

Execute the Day-to-Day Quality Assurance Tasks to Support Ongoing Manufacturing :

Review and approve executed electronic batch record comments and resolve discrepancies with manufacturing personnel.

Review and approve executed test results, perform review tasks in the laboratory information management system to issue Certificates of Analysis (COAs) as applicable.

Provide quality support for manufacturing operations in the cleanroom.

Be a quality point of contact for process support escalations, troubleshooting, triage and resolution.

Perform routine hands-on QA activities such as intake of incoming patient apheresis and drug product pack-out activities.

Compile, review and approve lot disposition records.

Perform routine raw material disposition and approve raw material specifications.

Perform review and approval of Deviation, Chage Control, CAPA, Excursion and Nonconformance record deliverables (as applicable).

Promote a culture of safety and GMP compliance.

Identify opportunities for continuous improvement.

Provide support to complex change controls (as applicable).

Support Process and / or Method Qualification and Validation activities by providing quality review of associated protocols, data and reports.

Perform internal audits (as applicable).

Support operational excellence initiatives.

KNOWLEDGE, SKILLS AND ABILITIES :

Experience in clinical and cGMP manufacturing required.

Experience with electronic quality management systems (e.g. deviations, CAPAs, change management) required.

Ability to work effectively both independently and with a team to set goals, develop sound project plans, monitor progress, and report results.

Excellent communication, emotional intelligence and interpersonal skills.

Motivated and organized critical thinker with solid cross-collaboration and business communication skills.

Fast learner, adaptable, with creative problem-solving skills.

Ability to work efficiently, prioritize workflow, meet deadlines and balance competing

The desire and ability to work in a fast-paced, start-up environment.

Excellent analytical skills and scientific / technical expertise.

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Company Description

Founded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct / contractual relationships with all our clients. Please visit our website www.talentburst.com or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA

Company Description

Founded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct / contractual relationships with all our clients. Please visit our website www.talentburst.com or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA