Quality Assurance Specialist
Merck Healthcare KGaA
Summary
MilliporeSigma has an opening as a Quality Assurance (QA) Specialist at our Round Rock location. In this role you will efficiently review and release quality production documents ensuring QA activities are aligned with quality documents and procedures in addition to customer and market requirements.
Job description
Your Role
MilliporeSigma has an opening as a Quality Assurance (QA) Specialist at our Round Rock location. In this role you will efficiently review and release quality production documents ensuring QA activities are aligned with quality documents and procedures in addition to customer and market requirements.
- Coordinate and perform review and approval of completed batch records, raw material records, validations, stability records, and other quality documents to ensure compliance with applicable procedures, test specifications and methods.
- Perform document record review and approval of batch records, analytical methods, method validations, stability protocols, and other quality documents for completeness and accuracy.
- Generate and review Certificate of Analysis (CoA) for catalog and custom projects.
- Generate quarterly metrics summarizing documentation review and production activities.
- Perform review and approval of Standard Operating Procedures to ensure compliance with regulatory and company quality requirements.
- Regularly communicate with QA management any problems and concerns that may delay or lead to the failure of the completion of projects, qualifications, validations, or other quality documents.
- Support rollout of local and corporate initiatives.
Who You Are
Minimum Qualifications: Bachelor's Degree in Chemistry, Biology, or other Life Science discipline.
Preferred Qualifications: Knowledge of ISO 9001, ISO 17025, ISO 17034 and ISO 14001. Knowledge of quality system requirements of the pharmaceutical and/or clinical industries. Excellent communication skills. The ability to respond to colleagues effectively, both verbally and in writing. The ability to interact and work well with other team members. Strong technical knowledge base and the ability to comprehend and communicate basic technical concepts. Self-motivated and able to work independently.
Requirements
- Bachelor's Degree in Chemistry, Biology, or other Life Science discipline
- Knowledge of ISO 9001, ISO 17025, ISO 17034 and ISO 14001
- Knowledge of quality system requirements of the pharmaceutical and/or clinical industries
- Excellent communication skills
- Ability to respond to colleagues effectively, both verbally and in writing
- Ability to interact and work well with other team members
- Strong technical knowledge base
- Self-motivated and able to work independently
Benefits
- Health Insurance
- Paid Time Off
- Retirement Contributions
Company overview
Merck Healthcare KGaA is the healthcare business sector of the Merck Group, a German multinational science and technology company headquartered in Darmstadt. Founded in 1668, Merck is the world's oldest operating pharmaceutical and chemical company. The Healthcare division focuses on developing innovative therapies across multiple therapeutic areas including oncology, neurology & immunology, fertility, and cardiovascular, metabolic, and endocrinological disorders. With approximately 62,557 employees globally, Merck Healthcare operates in more than 65 countries and generated 40% of the Group's sales in 2024. The company's oncology portfolio includes blockbuster products like Erbitux (cetuximab) for colorectal and head and neck cancers, Bavencio (avelumab) for urothelial carcinoma, and Tepmetko (tepotinib) for MET-altered cancers. In neurology, Mavenclad (cladribine) has achieved blockbuster status for treating relapsing multiple sclerosis, while the fertility division has helped bring over 6 million babies into the world through products like Gonal-f. Merck Healthcare combines a strong established business with specialty innovation, delivering a diversified portfolio of therapies to millions of patients worldwide.