Lead Associate, QA Compliance- Nights

Jubilant Pharma, LLC; Spokane (WA); On-site; USD 77,969 - 101,200; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) with company match

Generous paid time off plan

Employee Assistance Program

Job summary

Jubilant Pharma, LLC is seeking a QA Compliance Lead Associate to provide comprehensive support for quality systems and compliance. This is a full-time, on-site position located in Spokane, WA.

The ideal candidate will have an Associate’s Degree in a relevant field with 5 to 10 years of related experience. Responsibilities include facilitating deviations investigations, ensuring product compliance, and preparing CAPA metrics.

Competitive wages range from $77,969 to $101,200 annually with benefits including medical, dental, vision, and a generous paid time off plan.

Qualifications

• 5 to 10 years related experience required with an Associate’s Degree.
• Minimum of 3 years related experience required with a Bachelor’s Degree.
• Pharmaceutical and FDA Regulated Experience required.
• Direct or supporting aseptic manufacturing experience in biopharma industry desired.

Responsibilities

• Provide support to the company Deviations, CAPA program.
• Review deviations, investigations and CAPAs for compliance.
• Interface with management to ensure task completion.
• Provide deviations and CAPA metrics for management review.
• Speak to deviations during regulatory audits.

Skills

Technical writing

Investigations

CAPA system

Quality Assurance operations

Quality Control analysis

Education

Associate’s Degree in Biology, Chemistry or related field

Bachelor’s Degree in a science field

Tools

Microsoft Word

Microsoft Excel

Job description

JOB DESCRIPTION

Jubilant HollisterStier Spokane is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Jubilant HollisterStier LLC, Spokane’s Largest Manufacturing Company, and well-established member of the business community, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. Jubilant HollisterStier is a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.

Our Promise: Caring, Sharing, Growing

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions through growth, cost effectiveness and wise investment of resources.

Job Description:

The QA Compliance lead Associate provides support to the company Deviations, Corrective and Preventive Action (CAPA) program through a complete assessment of Root Cause Analysis (RCA) of deviations and vendor complaints/issues. Assures product compliance and product safety. Ensures accurate and timely data entry and oversight of the company Quality Systems related to Deviations, CAPA and vendor complaint activities.

• Review deviations, investigations and CAPAs to ensure accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations.
• Accountable for facilitating deviations investigation/resolution, assessing product impact and for completing/writing final assessment/lot disposition for QA Management and Client review and approval.
• Enters data into database in support of the corporate RCA and CAPA activities.
• Provide oversight of investigational RCA group activities including preparation of meeting agenda, providing necessary information to meeting participants, publishing of meeting minutes, and follow-up on agreed upon activities and tasks.
• Interface with management and responsible individuals to assure task completion on or before established due dates.
• Responsible for supporting quality systems, processes and procedures (e.g. Deviations, CAPA, Vendor complaint, etc) to assure compliance and product quality and safety.
• Accountable for assisting the QA and applicable Department Management to ensure and follow up on implementation of corrective actions that stem from deviations, audit or regulatory inspections.
• Provide deviations and CAPA metrics as needed in support of management review of system data.
• Work extensively with appropriate department(s) to gain an understanding of the production/analytical testing process and other applicable process to ensure capture of appropriate details and conclusions in the investigation or corrective action documents.
• Provide investigation training as needed to the Quality Unit and other departments to ensure that investigations are handled consistently throughout the company.
• Speak to deviations during regulatory and client audits.
• Assist with reviews and approval of minor deviations in the QMS system.
• Assist with extension requests approvals when permitted by procedure.
• Assist with RCA chart review for the QAC team members.
• Act as QA SME on Change Control records within the QMS.
• Provide leadership and guidance to QAC team members.
• Report performance issues to QAC supervisor as they arise.
• Act as the QA Compliance Supervisor when requested by the QA Manager (in the absence of the supervisor).

Qualifications:

• Associate’s Degree in Biology, Chemistry or related field required.
• Bachelor’s Degree in a science field desired.
• 5 to 10 years related experience required with an Associate’s Degree required.
• Minimum of 3 years related experience required with a Bachelor’s Degree required.
• 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.
• Direct or supporting aseptic manufacturing experience in biopharma industry desired.
• Lead and Supervisory desired.
• Ability to lift 30 pounds unassisted required.
• Microsoft Word & Excel experience required.
• Knowledge of cGMPs desired.
• Prolonged sitting required.

This is a full‑time, on‑site position located in Spokane, WA.

• Hiring Wage: $77,969.00 – $101,200 annually depending on experience, with opportunity for growth, promotion and annual raises. Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role.
• Medical, Dental, Vision, Flexible Spending and Health Savings Accounts.
• Life, AD&D, Short and Long Term Disability.
• 401(k) with company match.
• Generous paid time off plan.
• Employee Assistance Program.