A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 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 Control (QC) Analyst will be part of the Quality team and responsible for performing various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods and ensure compliance with established standards. Additionally, the Sr. QC Analyst will support non-routine QC tasks such as owning/completing non-conformances and corrective actions (CAPAs) and improvement projects. Support the day-to-day activities of the Quality department while adhering to applicable regulatory requirements, ISO 13485, local and global QMS.
Essential Duties and Responsibilities:
•Performs various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods and ensure compliance with established standards.
•Conducts and validates various biological and chemical quality control (QC) assays (method validation).
•Write, revise and/or review Standard Operating Procedures while adhering to regulatory requirements.
•Maintain extensive knowledge of Standard Operating Procedures and GMP regulations and guidelines.
•Troubleshoot equipment problems.
•Recognize atypical and out of specification results, instrument malfunctions, and methodology issues and participate in the investigation process.
•Perform investigations pertaining to non-conformances/CAPA
•Maintain cGMP compliance in the laboratory.
•May require work on various projects to improve efficiency or compliance.
•Additional responsibilities may be assigned by Supervisor or Manager as needed to support the Organization.
General Responsibilities and Authority:
•Understands, supports, and communicates Company mission, vision, and values.
•Understands and follows the requirements of the quality system.
•Adhere to cGMP, company policies, and company standards.
•Recommends, provides, or initiates solutions by actively providing suggestions for improvement.
•The individual must be detail-oriented and disciplined to adhere to strict deadlines.
•Maintain and demonstrate a high level of personal and professional integrity and report any suspicious activity to laboratory management.
•Must be willing and able to work on weekends or extended hours as needed.
Who You Are:
•Bachelor’s degree in a biological science or equivalent life sciences degree
•3+ years’ experience performing quality control testing for incoming material, in-process material and/or finished goods in a regulated environment.
•4+ years of experience in an FDA/ISO or other regulated environment is required.
•Knowledge and experience in IHC, ELISA and Bioburden highly preferred.
•Knowledge of SAP and/or SAP NEXT highly preferred.
•General knowledge of FDA QSRs cGMP, and ISO 13485 or other related industry standards is preferred.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill 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!
Curious? Apply and find more information at come2emd.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 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.