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Quality Assurance, Senior Associate (Compliance)
A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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 Quality Assurance compliance representative is a highly dynamic customer facing position offering a world class experience for our customers.
CQA possesses detailed knowledge of cGMP and site quality systems with strong evidence of collaborating in a matrix environment. Highly developed interpersonal, written and verbal skills, including the ability to communicate with client and represent the Madison/Verona quality management system. The CQA must be able to establish strong collaborative relationship with all departments within the organization to deliver on customer commitments.
Duties include but are not limited to:
- Developing and implementing programs to establish and maintain quality standards of existing products and services, as well as developing programs to focus employees on quality improvement.
- Implementing policies, procedures and methods to check product, material, components and/or operational quality and improve same.
- Ensuring quality of products, services and suppliers in compliance with product claims, external regulations and customer quality requirements.
- Maintaining and communicate a clear quality vision for the safe, efficient and compliant production of APIs and other GMP compounds.
- Ensuring the organization has an ‘Inspection Ready’ program with personnel preparation for hosting inspections and inspection follow up.
- Maintaining Site’s Quality and Regulatory Heat Map with responsibility for risk reduction programs and support the initiation and review of quality improvement plans.
- Providing GMP training and governance to the site and responsible for site training program (Learning management system (LMS).
- Ensuring that Deviation, and CAPA follow adherence to GMP and closure times and the management of TrackWise.
- Making sure that critical deviations are investigated and resolved.
- Ensuring that the Change control programs follow adherence to GMP and closure times and the management of TrackWise.
- Approving changes that potentially affect intermediate or API quality.
- Owner of the Data integrity plan and execution as per project plan.
- Managing customer complaints and associated reports Making sure that quality-related complaints are investigated and resolved.
- Responsible for the implementation of policies, procedures and methods to check product, material, components and/or operational quality and ensures implementation of corporate policy and procedures.
- Approving all specifications and master production instructions.
- Approving all procedures affecting the quality of intermediates or APIs.
- Overseeing external audits program, regulatory and customer.
- Ensuring that internal audits (self-inspections) are performed.
- Reviewing and approving validation protocols and reports.
- Preparing and performing QMR and APR appropriate to the GMP and products.
- Frequent interaction with internal teams to support product license and regulatory submissions with the regulatory affairs group.
- Maintaining the Approved Supplier List (ASL) including updating and reviewing performance of vendors and ensuring Quality Agreement with vendors are established and maintained.
- Approving intermediate and API contract manufacturers and testing facilities.
- Providing compliance review for documentation including change controls, deviations, validation documentation, SOPs and specifications.
- Management of Customer Quality Agreements.
- Providing Quality Compliance support to new product introduction (NPI) activities.
- Reviewing requests for major changes and PDP/TDP gate reviews and makes recommendations.
- Management of critical quality incidents and Field corrective actions (FCA) and product returns as necessary, interact with authorities with the support of the regulatory team.
- Supporting the initiation and review quality improvement plans.
- Collate and deliver weekly and Monthly KPIs to Management.
Who you are:
- Bachelor’s Degree in chemistry, Biochemistry, or a related life science
- Strong written and verbal communication skills.
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!
Curious? 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.