Sr. Quality Assurance Specialist, Audits
MilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.
Oversees client and regulatory audits. Schedule and host audits and manage audit responses. Lead internal audit program. Grow the supplier auditing program. Provides compliance direction to internal employees and sets compliance policy for the site. Monitors and evaluates products, processes, facilities, etc, to ensure that standards of quality are being met and prepares audit reports. Ensure alignment with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP), confirming that both internal and external procedures and regulations are followed. Responsible for the development, implementation and follow-up of audit programs according to an audit master. After the audits are performed and reported, the group assesses Corrective and Preventive action (CAPA) plans (proposed by the auditees) for appropriateness.
Works with substantial discretion and uses best practices and knowledge of internal or external business issues to improve products or services.
Uses specialist knowledge, analytical skills, judgment and broad conceptual and practical experience to solve complex problems and to contribute to process improvements.
Understands how the different teams jointly achieve the objectives of the area and uses knowledge of the organization, processes, customers and key business drivers to increase effectiveness.
Set compliance policy for site, with input from Executive management.
Implement supplier and internal auditing programs.
Provide training courses to internal employees on compliance related topics.
Coordinate training program and provide oversight to departmental training coordinators.
Provides Compliance oversight to Non-Conformance/CAPA (NC/CAPA) program:
* Ensures trending is performed, review trends, and report to management
* Track status of compliance related documentation, including closure rates
Comply with cGMP Documentation:
* Record information accurately
* Make corrections in a timely manner
* Review pre-recorded data for accuracy and completion
* Ensure all entries are neat and legible
* Follow up on documentation errors
Comply with cGMP Practices and Regulations:
* Understand, observe, and practice proper gowning
* Understand flow of personnel in the manufacturing areas
Compliance with Policies and Regulations:
* Compliance with 21 CFR - Parts 11, 210 and 211
* Compliance with SOPs
* Emphasize importance of quality cGMP compliant documentation to coworkers
* Act as a trusted and valuable resource
* Provide a positive reinforcing, open learning atmosphere
* Set a good example in observance of cGMP
* Supervise employee training in Quality Assurance responsibilities and cGMPs
Compliance with safety guidelines:
* Know appropriate emergency response procedures
* Know evacuation route and assembly area to be used in case of fire or earthquake
* Know the location of MSDS binders and understand how the guidelines pertain to employees
* Assume responsibility for compliance with safety guidelines
Audit Certification such as ASQ-CQA preferred
Bachelor of Science degree or equivalent work experience required
Minimum of 8 years of directly related experience preferred
Hosted FDA or International Regulatory Inspections preferred
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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.