Associate Specialist QA

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

Job Function

Quality

Job Sub Function

Quality Assurance

Job Category

Professional

All Job Posting Locations

Sassenheim, Netherlands

Job Description

The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.

Essential Job Duties and Responsibilities

The Associate Specialist QA acts as a quality expert and applies our Quality Systems to create, review and approve GMP documentation as needed for the commercial products at our manufacturing facilities, including Batch release. The Associate Specialist QA works in close collaboration with other departments (Operations, QC, MAM and MSAT, and other site Quality departments).

Principal 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; , including 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

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 required for the position: Degree in science related subject and /or business-related area with 2-4 years of experience in a GMP regulated environment (manufacturing, QA and/or QC) in a pharmaceutical company. QA experience preferred.

Preferred 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

Salary

The anticipated base pay range for this position is: €38300,00 - €61410,00

Benefits

• an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees' and companies' performance of the previous calendar year, or sales commissions.
• Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health.
• We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location's eligible dependents - can participate in several insurance plans.
• For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com/.