Senior Quality Assurance Associate, QA Product Release

The businesses of Merck KGaA, Darmstadt, Germany•St. Louis, MO

52d•$27 - $42

About The Position

The key responsibilities of a Quality Assurance Senior Associate, QA-Product Release include the following: Evaluate raw material or final product (repack or manufactured) supply chain to determine acceptability to meet import/export requirements that were derived from animal by-product (ABP). Ensure that all aspects of routine product assignment and release for raw materials and finished goods meet analytical, packaging, and labeling specifications in accordance with establishedquality systems and regulatory/industry requirements. Technical/consultative expert for risk assessment evaluations & implementation of mitigation strategies related to; pathogenic agents, sourcing origin, genetically modified organisms, residual solvents, and/or heavy metals within the supply chain. Report results (Certificate of Origin, customer, or regulatory questionnaires) product assessments as part of product release or as requested by Project Management, Tech Service, Customers, Sales, Marketing and/or regulatory agencies. Inspection and final usage decision of critical raw materials used in production to specifications. Ensure these specifications are managed to latest regulatory and/or industry requirements in coordination with internal and external functions. Perform product specific projects to improve product quality performance, product quality information and/or improve customer satisfaction as requested by Project Management, Tech Service, Sales, and/or Marketing.

Requirements

Bachelor's Degree in Life Science (Chemistry, Pharmacy, etc) or Engineering (Chemical, Process, etc) and 2+ years of experience working in the life science industry.
Associate’s Degree and 5+ years working experience in a Quality Assurance role.
Bachelor’s Degree in any discipline and 5+ years working in a Quality Assurance role.

Nice To Haves

Knowledge of ISO 9001 and ISO 13485 and regulatory compliance issues (i.e., FDA, USDA, ICH, EDQM, IVDR) related to biologic derived materials, and prior experience working in a controlled/regulated environment.
Current fine chemical industry knowledge &/or experience desired.
Good computer skills, including proficiency in MS Word, MS Excel, MS Access, MS Project, MS PowerPoint, and ability to learn and operate using other specific application software (SAP, Trackwise, etc.)
Good communication (verbal & written) and customer services skills.
Good writing skills and experience writing procedures & report.
Ability to simultaneously manage multiple tasks/priorities.
Good problem-solving skills/abilities.
Good time management and negotiating skills.
Capacity for independent work.

Responsibilities

Evaluate raw material or final product (repack or manufactured) supply chain to determine acceptability to meet import/export requirements that were derived from animal by-product (ABP).
Ensure that all aspects of routine product assignment and release for raw materials and finished goods meet analytical, packaging, and labeling specifications in accordance with establishedquality systems and regulatory/industry requirements.
Technical/consultative expert for risk assessment evaluations & implementation of mitigation strategies related to; pathogenic agents, sourcing origin, genetically modified organisms, residual solvents, and/or heavy metals within the supply chain.
Report results (Certificate of Origin, customer, or regulatory questionnaires) product assessments as part of product release or as requested by Project Management, Tech Service, Customers, Sales, Marketing and/or regulatory agencies.
Inspection and final usage decision of critical raw materials used in production to specifications.
Ensure these specifications are managed to latest regulatory and/or industry requirements in coordination with internal and external functions.
Perform product specific projects to improve product quality performance, product quality information and/or improve customer satisfaction as requested by Project Management, Tech Service, Sales, and/or Marketing.