Senior Quality Assurance Associate, QA Product Release
Merck Group - St Louis, MO
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Work Location: St. Louis, Missouri Shift: Department: LS-SC-PMLQ4B Operational QA Broadway Recruiter: Guadalupe Barragan Hiring Manager: Larry Gunderson This information is for internals only. Please do not share outside of the organization. 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. Physical Requirements: 70% - 90% Office Environment, 10% - 30% Production, QC, Packaging. Who You AreMinimum Qualifications: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. ORAssociate's Degree and 5+ years working experience in a Quality Assurancerole. ORBachelor's Degree in any discipline and 5+ years working in a Quality Assurancerole. Preferred Qualifications: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. RSREMD Pay Range for this position: $27.00-$42.00 per hour. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
Created: 2026-03-04