What are the responsibilities and job description for the Quality Assurance Specialist position at Merck Group?
Work Location : Round Rock, Texas
Shift :
Department : LS-SC-PUKRAC Quality Assurance
Hiring Manager : Gail Spates
This information is for internals only. Please do not share outside of the organization.
Your Role :
A great opportunity has opened 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. Specific job duties include :
- 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, equipment qualifications, calibration records, analytical methods, method validations, stability protocols, and other quality documents for completeness and accuracy
- Generating and review Certificate of Analysis (CoA) for catalog and custom projects
- Assist in preparation and hosting external audits including customer, ISO, and DEA audits
- 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 the 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
- Assist with internal audits as needed to maintain audit schedule
- Support rollout of local and corporate initiatives
Who You Are :
Minimum Qualifications :
Preferred Qualifications :
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.
