Associate Quality Assurance Specialist
MilliporeSigma plays an integral part in the life science community, harnessing our passion and innovation to help researchers and drug producers around the world. As science advances, we advance with it, offering new insight and cutting-edge technologies helping our customers solve the world's most challenging human health issues. Our promise to our customers is that we'll be there every step of the way. MilliporeSigma is a division of Merck KGaA, Darmstadt, Germany. Merck KGaA, Darmstadt, Germany is a global pharmaceutical and chemical company with a history that began in 1668, and a future shaped by around 40,000 employees in 64 countries.
Spec, Quality Assurance Associate
PURPOSE OF THE POSITION
Ensure that all aspects of product release meet analytical, production, packaging and labeling specifications in accordance with established quality systems. Support the maintenance, development and improvement of GMP quality systems, such as auditing (internal, supplier, and customer), training, process validation, cleaning validation, equipment qualification, environmental monitoring, water monitoring, change control, complaint handling, and documentation control.
ESSENTIAL JOB FUNCTIONS
Review executed GMP batch documentation to determine whether process and laboratory results meet the predetermined acceptance criteria for release. Report all process deviations and/or laboratory OOS results.
Write, review, and/or approve Operating Procedures, Manufacturing documents and other QA controlled documents under Quality Management System (QMS).
Interact with the production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
Support quality systems such as internal and external audits, deviation, CAPA, change control, and customer complaints.
Education and Experience:
Bachelors degree in a Life Science or related field with 0-2 years experience in GMP manufacturing, validation, QA, QC, or other functional area applicable to the job or an Associates degree with 3-5 years applicable GMP experience in the specific QA job function as deemed appropriate by QA Management or at least 5 years experience with a degree not specified in Life Science
Knowledge and Skills:
- General understanding of Good Manufacturing Practices and ISO 9001:2008
- Good computer skills, including proficiency MS Word and MS Excel.
- Good time management skills.
- Excellent interpersonal skills for interacting with many internal departments.
- Ability to organize and prioritize tasks effectively.
- 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, 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.