What are the responsibilities and job description for the Sr. Quality Assurance Associate Specialist position at Merck KGaA?
Your Role
At MilliporeSigma, the QA Product Release Specialist will perform a variety of functions according to established protocols to support quality review and release of purchased and produced goods prior to downstream use and delivery to customers. Role responsibilities include the following:
Evaluate raw material or final products (repack or manufactured) to determine acceptability to meet import/export requirements that are 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 established quality systems and regulatory/industry requirements.
Technical/consultative expert for risk assessment evaluations & implementation of mitigationstrategies related to; pathogenic agents, sourcing origin, genetically modified organisms, residual solvents, and/or heavy metals within the supply chain.
Review vendor documentation (certificate of origin, customer or regulatory questionnaires, etc.) as part of product release or as requested by Project Management, Technical Services, Customers, Sales, Marketing and/or regulatory agencies.
Assist with customer related documents, including supply chain declaration/affidavits and Certificate of Origin creation.
Perform product specific projects to improve product quality performance, product quality information and/or improve customer satisfaction as requested by Project Management, Technical Service, Sales, and/or Marketing.
Act as an auditor of the Internal Auditing Program.
Conduct Training (individual, group).
Batch review and usage decision.
Physical Attributes:
Environmental conditions: Varies depending on specific job responsibilities.
70%-90% office environment, 10-30% production, QC, and packaging on the floor engagement.
Who You Are:
Minimum Qualifications:
Associate Degree in Life Sciences, Chemistry, Pharmacy, Chemical or Process Engineering.
5+ years experience in a QA job function.
Preferred Qualifications:
2+ years experience in industry.
Knowledge of ISO 9001:2008 required, ISO 13485.
Knowledge of other regulatory requirements (i.e. USDA, FDA, EC, DEFRA, ICH, and EDQM).
Knowledge of animal/human pathogens.
Knowledge of transgenic plants and animals.
Current fine chemical industry knowledge and/or experience.
Knowledge of SAP - Resource Planning (ERP) Business tool related to COA generation and release of products.
Salary : $56,000 - $82,000