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Spec Quality Assurance Associate

Posted 18 Oct 2017

Carlsbad, California - United States

Req Id 163691

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 50,000 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.


Your role: Performs a wide variety of inspections, checks, and reviews for the manufacture of products and its associated documentation. Performs in process audits and accurately documents results. Ensures that materials and clinical products are manufactured in such a way as to maintain the identity, strength, quality and purity it purports to have.

Essential Functions:

  • Compliance with safety guidelines
    • Use safety eyewear while inside a manufacturing area
    • Know appropriate emergency response procedures
    • Know locations of first aid kits, safety showers, and spill kits
    • Know evacuation route and assembly area to be used in case of fire or earthquake
    • Know the location of MSDS and understand how the guidelines pertain to employees
    • Assume responsibility for compliance with safety guidelines
  • Perform lot file review, which will include batch records and associated documentation
    • Identify documentation and procedural errors
    • Communicate errors noted to operations staff
    • Notify client of deviations to procedure
    • Assemble lot file packages
    • Work with client QA representatives to address any comments/concerns regarding lot file packages and facilitate Release by the client
    • Participate in conference calls and/or team meetings to represent QA
  • Support Manufacturing operations from a QA function as required
    • Perform Line Clearances
    • Receive product from Manufacturing and store appropriately
    • Provide guidance to Manufacturing when requested
    • Verify shipping paperwork and real time shipping operations
    • May perform visual inspection on final drug product
  • Initiate Deviation documentation
    • Recognize common sources of failure
    • Assist in the formulation of corrective procedures
    • Work with QA and Operations personnel to improve compliance
  • Leadership
    • Emphasize importance of quality cGMP compliant documentation to coworkers
    • Act as a trusted and valuable resource
    • Provide a positive reinforcing, open learning atmosphere
    • Set a good example in observance of cGMP
  • Comply with cGMP Documentation
    • Record information accurately
    • Make corrections in a timely manner
    • Check all necessary calculations
    • Review pre-recorded data for accuracy and completion
    • Ensure all entries are neat and legible
    • Follow up on documentation errors
  • Comply with cGMP Practices and Regulations
    • Generate clear and concise labels for materials and final product
    • Understand, observe, and practice proper gowning
    • Understand flow of personnel in the manufacturing areas
  • Compliance with Policies and Regulations
    • Compliance with 21 CFR - Parts 11, 210 and 211
    • Compliance with SOPs
    • Compliance with Quality Agreements
  • Other duties as assigned.

Who you are:

  • Education: Bachelor of Science degree or equivalent work experience
  • Experience: Minimum of 4 years of directly related experience preferred
  • Essential and Critical Skills:
    • Working knowledge of process and desktop computers
    • Experience with cGMPs
    • Effective communication skills, both oral and written
    • Able to work well with other levels and departments within the company, individually and as part of a team.

ADDITIONAL LOCAL NEEDS

  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually low. The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision. The employee must be able to work off-shifts, weekends, and additional hours as required. The employee must have the ability to perform very complex tasks with attention to detail. The employee must be able to travel occasionally (5%).

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 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.

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