QA Associate Specialist: GMP & Batch Release Expert

7266-Janssen Biologics B.V. Legal Entity; Sassenheim; On-site; EUR 38,000 - 61,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson in Sassenheim, Netherlands, seeks an Associate Specialist QA to apply Quality Systems, review and approve GMP documentation including batch release for commercial products. You will collaborate with Operations, QC, MAM, MSAT and site QA teams to ensure compliance and continuous improvement.

The role focuses on reviewing QA documentation, participating in audits, and supporting quality initiatives across the site in a GMP environment.

Qualifications

• Minimum Qualification: BSc in science related subject and/or business-related area with 4 years of experience.
• MSc in science related subject and/or business-related area with 2 years of experience.
• Minimum experience in GMP regulated environment (manufacturing, QA and/or QC) in a pharmaceutical company; QA experience preferred.

Responsibilities

• Review and approve routine GMP documentation for all components of the Quality system.
• Review and approve release documentation for raw materials or Drug Substance; QA review of batch records and related documentation (e.g., QC test results, QC trending data, SAP tags and related change controls).
• Review and approve Maintenance notifications and work orders (NI-NS) and SAP-PM Master Data Changes (N2, N5 and N6), as well as the approval of Maintenance and Calibration related documents (as needed).
• Perform the Quality review of Periodic Review reports.
• Quality overview of the validated state of the utilities, equipment and processes.
• Provide Site support for local or global improvement initiatives as an SME or QA core team member.
• Collaborate with QA site and global colleagues;
• Executes Quality Aseptic Processing Oversight activities, verifying that operations are executed as supposed to and supports various Quality on the floor initiatives.
• Engages in internal audits and inspections as an SME or in support functions

Skills

Analytical Reasoning

Business Behavior

Compliance Management

Detail-Oriented

Execution Focus

Goal Attainment

Human-Centered Design

Internal Controls

Process Oriented

Quality Assurance (QA)

Quality Control (QC)

Quality Management Systems (QMS)

Quality Processes

Quality Standards

Education

BSc in science related subject

MSc in science related subject

Tools

SAP

Job description

Johnson & Johnson in Sassenheim, Netherlands, seeks an Associate Specialist QA to apply Quality Systems, review and approve GMP documentation including batch release for commercial products. You will collaborate with Operations, QC, MAM, MSAT and site QA teams to ensure compliance and continuous improvement.

The role focuses on reviewing QA documentation, participating in audits, and supporting quality initiatives across the site in a GMP environment.