Senior Associate QA

We are looking for an outgoing, multi-tasking mediator with strong communication skills and the ability to work under pressure. This is a highly dynamic and fast-paced role within a GMP-regulated manufacturing environment, where daily reprioritization and immediate response to production-related quality issues are required. GMP experience is a plus.

Please note! This is a 3-shift job with the following shift structure: One week night shift - 22.30 - 07.00 - 61% shift allowance One week late shift - 14.30 - 23.00 - 28% shift allowance One week early shift - 06.30 - 15.00 - 4% shift allowance One week late shift - 14.30 - 23.00 - 28% shift allowance One week early shift - 06.30 - 15.00 - 4% shift allowance

Night shift occurs approximately one week every five weeks. Full on-site presence is required.

A driver’s license is strongly preferred due to early shift timing and reliability of transportation. Alternatives are acceptable if punctuality can be guaranteed. 100% commitment is needed.

Objectives: Provide QA guidance and support in the production area at ABR within the Planned Quality Assurance (PQA) team, responsible for quality oversight of labeling and packaging operations. Perform batch record review of batches assembled, packaged and labeled at ABR, ensuring full GMP-compliant documentation and proper exception handling. Establish effective working relationships with Production, Warehouse, Maintenance and Engineering, QA Management and the Qualified Person. Provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions. Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations and triage production issues together with Production, Maintenance and Engineering. Review and approve batch production record data entries before production activities take place. Perform QA pack checks (inspection of finalized packs before production continues). Perform finished product checks during (commercial) production runs. Compile and review batch records for lots assembled, packaged and labeled at ABR in preparation for disposition by QP. Perform GMP compliance checks in production. Review and approve deviation records and support deviation handling. Initiate and own QA deviations as needed. Act as QA contact for production-related quality issues during shifts. Act as author for operational SOP’s and Work Instructions, as needed. Review of operational SOP’s and Work Instructions, as needed. Assist in development and delivery of GMP training activities for QA and production staff. Participate in QA production related projects, as needed. Assist in various investigations, as needed. Assist in ABR projects and improvement efforts, as needed. Responsible for preparation of weekly/monthly metrics. Own and maintain departmental performance boards.

Knowledge: Understanding and application of principles, concepts, theories and standards of technical/scientific field. Specialized knowledge within own specialty area. Deepens technical knowledge through exposure and continuous learning. Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.

Problem Solving: Applies research, information gathering, analytical and interpretation skills to problems of diverse scope. Ensures compliance within regulatory environment, even under time pressure and when quality decisions impact production timelines. Develops solutions to technical problems of moderate complexity. Screens, categorizes, evaluates, reconciles, reports and resolves data integrity issues. Interprets generally defined practices and methods.

Autonomy: Works under general direction. Work is guided by objectives of the department or assignment. Refers to technical standards, principles, theories and precedents as needed. May set project timeframes and priorities based on project objectives and ongoing assignments. Recognizes and escalates problems.

Contribution: Contributes to the work of group/team by ensuring the quality of the tasks/services provided by self. Contributes to the completion of milestones associated with specific projects or activities within own department or workgroup. Provides training/guidance to others and acts as a technical/scientific resource within work group/team. Establishes working relationships with others outside area of expertise. Works collaboratively across shifts to ensure continuity and consistency in quality oversight.

Minimum Requirements: MBO or BSc degree in Pharmaceutical/Life Sciences or related field or the equivalent combination of education and/or experience. Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical, medical device or other regulated industry (e.g. food industry) with experience in batch record review and investigations. QA experience is preferred; manufacturing experience is beneficial for understanding the environment. QC backgrounds are acceptable if motivated to transition into QA. Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases. GMP/GDP experience is preferred but not a strict requirement. Experience with Manufacturing and/or Quality analytical processes and operations. Fluent in English language. Strong soft skills including stress resilience, stakeholder management, clear communication, planning and organizational skills, and the ability to stand firm when making quality decisions that may impact production.

Training & Development: Extensive training period (approximately 4–9 months to become fully qualified in issue handling and independent QA decision-making). Strong intention to extend contracts and potentially convert to permanent positions depending on performance and business needs.

Start date:

As soon as possible.