A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 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 Carlsbad Gene Therapy Viral Vector Manufacturing is a contract manufacturing site that produces drug substance and drug products for gene therapy and oncology applications. We are currently seeking an individual to join our Client Facing Quality Assurance team. This key role will be performing disposition of product and actively supporting our clients.
As a member of the Client Facing Quality Assurance team, you will be responsible for the critical, quality review and disposition of raw materials and product batch records. This role requires the ability to effectively communicate with clients, independently manage timelines, and continually strengthen client relations. You will need to be organized and detail oriented with strong and effective written, verbal, mathematical, and interpersonal communication skills. This role will require you to have the ability to work independently within prescribed guidelines and collaboratively as part of a team as well as be able to obtain direction and commitment to ensure that projects are completed by deadlines and streamlining processes to maximize productivity. This role will also require the ability to work successfully, strategically and tactically in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions. Off-shift, weekend, and overtime duties may be required as assigned by the manager of the employee. Additional responsibilities of this role may include:
- Performing product inspections and facility inspections
- Line clearances
- General product observation
- Reviewing process validation documentation,
- Logging and monitoring quality related data.
- Other Quality Assurance related duties and projects as assigned
- Constantly sitting and reaching to use computers and other office equipment
- Constantly viewing objects at close and distant ranges
- Employee frequently works in a professional office environment with computer equipment and at times within a manufacturing and laboratory environment with machinery, tools, and moderate amounts of noise and activity.
- Employee may occasionally be exposed to fumes, airborne particles, chemicals, vibration and biohazardous materials.
- The work environment is fast-paced and demanding.
Who you are:
- High School Diploma or GED equivalent and 3+ years’ experience in Biologics, Pharmaceuticals or Medical Devices.
- 3+ years of experience working within Quality in a cGMP environment
- 2+ years of experience creating, revising, reviewing, and approving of controlled documentation
- 2+ years’ experience supporting client audits and regulatory inspections
- Bachelor’s degree in a scientific discipline
- 2+ years of Contract Manufactured Organization (CMO) experience
- 2+ years’ experience identifying, communicating, investigating, and driving quality system events to completion
- Knowledge of governmental regulatory guidelines, directives, and regulations relating to the manufacture of biologics and pharmaceuticals
- Cleanroom experience
- Experience performing internal audits
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.