Merck Group
Work Location: St. Louis, Missouri
Shift:
Department: LS-SC-PMLQ4C QAPR
Recruiter: Guadalupe Barragan
Hiring Manager: Rebecca Mueller This information is for internals only. Please do not share outside of the organization.
Your Role:
The Quality Assurance Associate Specialist role ensures product batches meet regulatory and quality standards before release. This role involves the release of batches, creation of CoAs, audit support and close collaboration with production teams to resolve any issues.
Ensuring the adherence to safety and quality regulations, specifications, and policies to enable strong delivery to the customer. Enabling team members to pre-empt injuries and quality non-conformances by using data-driven insights, formal risk assessments, and proactive safety and quality observations. Align quality capabilities with customer expectations, ensuring products meet not only compliance requirements but also specific customer demands for quality, customization and crucially the overall customer experience. Utilizing an operational mindset to standardize global test methods and drive efficiencies by optimizing key processes such as capacity planning, performance management and consumables management. Foster a collaborative approach between production, engineering and quality to drive shared ownership of quality outcomes and upskill production operators and process engineers in quality requirements and processes to facilitate in-process testing, process optimization and autonomous decision making. Excel in understanding and ensuring products meet and maintaining thorough documentation for audits and inspections. quality standards and regulatory requirements.
Who You Are
Minimum Qualifications:
Associate's Degree in Life Science (Biology, Chemistry, etc.) or Engineering (Process, Chemical, etc.) 1+ years of life science industry experience.
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. 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.). Communication (verbal & written) and customer services skills. Experience writing technical documentation & reports. Ability to simultaneously manage multiple tasks/priorities. Good problem-solving skills/abilities. Good time management and negotiating skills. Capacity for independent work.
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.
Hiring Manager: Rebecca Mueller This information is for internals only. Please do not share outside of the organization.
Your Role:
The Quality Assurance Associate Specialist role ensures product batches meet regulatory and quality standards before release. This role involves the release of batches, creation of CoAs, audit support and close collaboration with production teams to resolve any issues.
Ensuring the adherence to safety and quality regulations, specifications, and policies to enable strong delivery to the customer. Enabling team members to pre-empt injuries and quality non-conformances by using data-driven insights, formal risk assessments, and proactive safety and quality observations. Align quality capabilities with customer expectations, ensuring products meet not only compliance requirements but also specific customer demands for quality, customization and crucially the overall customer experience. Utilizing an operational mindset to standardize global test methods and drive efficiencies by optimizing key processes such as capacity planning, performance management and consumables management. Foster a collaborative approach between production, engineering and quality to drive shared ownership of quality outcomes and upskill production operators and process engineers in quality requirements and processes to facilitate in-process testing, process optimization and autonomous decision making. Excel in understanding and ensuring products meet and maintaining thorough documentation for audits and inspections. quality standards and regulatory requirements.
Who You Are
Minimum Qualifications:
Associate's Degree in Life Science (Biology, Chemistry, etc.) or Engineering (Process, Chemical, etc.) 1+ years of life science industry experience.
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. 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.). Communication (verbal & written) and customer services skills. Experience writing technical documentation & reports. Ability to simultaneously manage multiple tasks/priorities. Good problem-solving skills/abilities. Good time management and negotiating skills. Capacity for independent work.
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.