MilliporeSigma Sr. Quality Assurance Associate - 693624301 in Topeka, Kansas
This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/ada/r/jobs/11565749 A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
The Senior Quality Assurance Associate Specialist job functions are to:
+ Ensures that all aspects of product manufacture meet production, packaging, labeling, and test specifications in accordance with established quality systems.
+ Support the maintenance, development, and improvement of quality systems, such as auditing (internal, supplier, and customer), training, document change control, specifications, master batch records.
+ Make batch release determination and generate CoA and other specified batch documents.
+ Review and release raw materials in a timely manner, assuring any lot deviations, and Out of Specifications (OOS) are completed and closed.
+ Label approval, label generation, troubleshoot label issues as needed.
+ Review batch records prior to production.
+ Review and release finished products in a timely manner, assuring any lot deviations, Non-permanent changes are completed and closed.
+ Answer questions from internal and external customers.
+ Participate in cross-functional deviation investigations, root cause analysis, and CAPA plan development in a timely manner. Maintain CAPA tracking and perform effectiveness checks as applicable.
+ Participate in customer and ISO audits including opening/closing meetings, tours, document review, and any follow-up activities, as necessary.
+ Conduct periodic internal audits to meet regulatory requirements.
+ Approve master batch records, and batch records, assuring accuracy and completeness. Resolve any discrepancies in documentation.
+ Review and approve product specifications.
+ Take part in and contributes to a safe working environment by following corporate and departmental safety regulations.
+ Maintain Site Quality filing systems as necessary.
+ Participate in the Quality Assurance On-Call rotation with the rest of the QA Batch Release Team.
Who you are:
+ Bachelor's Degree in life sciences or related field
+ 1+ years of experience in direct Quality Assurance experience OR an equivalent combination of education and experience.
+ 3+ years of experience in a Pharmaceutical, Biopharma, or other Healthcare industry with demonstratable familiarity of cGMP's, cGLP's and/or related ISO requirements.
+ An understanding of commercial Quality systems and the application of them in a manufacturing environment.
+ Effective oral and written communication skills.
+ Ability to work as a team player and independently on projects.
+ Good customer service skills and the ability to negotiate win-win outcomes.
+ Strong attention to detail
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curiou s? Apply and find more information at https://jobs.vibrantm.com
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.
Job Requisition ID: 223843
Career Level: C - Professional (1-3 years)
Working time model: full-time