QA Compliance Lead - Immediate Impact & Day-One Benefits

Jubilant HollisterStier LLC; Spokane (WA); Presencial; USD 56.000 - 66.000; Tempo integral

Benefícios oferecidos por esta vaga

Day-one benefits

Career growth opportunities

On-site Spokane location

Resumo da vaga

Jubilant HollisterStier LLC in Spokane, WA seeks a Lead Associate - QA Compliance to manage deviations, CAPA and RCA for product quality and safety. The role oversees data entry, investigations, and QA systems alignment with regulatory expectations.

You will lead RCA activities, coordinate with management, provide training, and support audits. On-site, full-time, with a competitive wage and day-one benefits, fostering continuous improvement and growth.

Qualificações

• Associates Degree in Biology, Chemistry or related field required.
• 5 to 10 years related experience required with an Associate’s Degree.
• Pharmaceutical and FDA Regulated Experience required.
• Experience with technical writing, investigations, CAPA system, building and manufacturing processes/systems, QA operations systems, and QC analysis is required.

Responsabilidades

• Review deviations, investigations and CAPAs to ensure accuracy, consistency and compliance with SOPs/Policies and related guidelines/regulations.
• Facilitate deviations investigation/resolution and assess product impact; complete final assessment/lot disposition for QA management and client review.
• Enter data into database to support RCA and CAPA activities.
• Provide oversight of RCA activities including meeting prep, information sharing, minutes, and follow-up actions.
• Interface with management to assure task completion by due dates.
• Support quality systems and procedures to assure compliance and product quality and safety.
• Assist with implementation of corrective actions from deviations, audits or inspections.
• Provide deviations and CAPA metrics for management review.
• Work with departments to understand production/testing processes for accurate investigation documentation.
• Provide investigation training to QA and other departments to ensure consistency.
• Speak to deviations during regulatory and client audits.
• Assist with review/approval of minor deviations in QMS.
• Assist with extension requests approvals when permitted by procedure.
• Assist with RCA chart review for QAC team members.
• Act as QA SME on Change Control records within QMS.
• Provide leadership and guidance to QAC team members.
• Report performance issues to QAC supervisor.

Conhecimentos

Quality Assurance

Investigations

Technical writing

QA operations

QC analysis

Regulatory experience

cGMP knowledge

Bio/pharma manufacturing

Leadership

SOP compliance

Formação

Associate degree in biology/chemistry

Bachelor’s degree in science

Ferramentas

QMS software

Regulatory databases

Documentation systems

Descrição da vaga

Jubilant HollisterStier LLC in Spokane, WA seeks a Lead Associate - QA Compliance to manage deviations, CAPA and RCA for product quality and safety. The role oversees data entry, investigations, and QA systems alignment with regulatory expectations.

You will lead RCA activities, coordinate with management, provide training, and support audits. On-site, full-time, with a competitive wage and day-one benefits, fostering continuous improvement and growth.