Associate Specialist QA

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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.
• Knowledge of current Quality Management principles, GMP and Quality Systems, Pharma regulations.
• Knowledge of aseptic processing techniques and sterile manufacturing requirements is highly desired.
• Strong written and verbal communication skills to effectively negotiate and interact with various stakeholders.
• Problem solving, analytical thinking and decision making capabilities.
• Demonstrated proficiency in English both in word and in writing. Dutch is a pre but not mandatory.

Required Skills:

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

The anticipated base pay range for this position is:

€38 300,00 - €61 410,00

Benefits:

In addition to base pay, we offer the following 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.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.