21 days old

QA Lot Review Specialist

US06 Arch Chemicals Inc
Rochester, NY 14614
  • Job Code
    R15165

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. 

Our vision:

We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission:

We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
 

Do you want to help us as we shape the future of this great organization?

 

Job Description Summary

Lonza is an integrated solutions provider that creates value along the Healthcare Continuum. Through our Lonza Pharma Biotech & Nutrition segment and our Lonza Specialty Ingredients segment businesses, we harness science and technology to serve markets along this continuum. We focus on creating a healthy environment, promoting a healthier lifestyle and preventing illness through consumers' preventive healthcare, as well as improving patient healthcare by supporting our customers to deliver innovative medicines that help treat or even cure severe diseases.

Patients and consumers benefit from our ability to transfer our pharma know-how to the healthcare, hygiene and fast-moving consumer goods environment and to the preservation and protection of the world where we live.

Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 100 sites and offices and approximately 15,500 full-time employees worldwide at the end of 2018. The company generated sales of CHF 5.5 billion in 2018 with a CORE EBITDA of CHF 1.5 billion. Further information can be found at www.lonza.com.

The Opportunity

Great opportunity for a Lot Review Specialist!  Lonza Rochester produces biocides and personal care ingredients for the hygiene, preservation and personal care markets.  This site was acquired from Arch Chemicals and is the oldest continuing manufacturing facility in Rochester, NY.  Lonza offers a highly competitive salary, excellent benefits and a 401K. 

Quality should be the responsibility of all persons involved in Manufacturing. Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc).  Responsible for supporting the Lonza philosophy, "The Vision is Zero" in his/her job routine.  Works to attain the purpose, "Zero injuries, Zero process incidents, Zero distribution incidents, and Zero environmental incidents."

Description:

Full review of completed batch records to ensure compliance with cGMP per written procedures.

  • Working knowledge of Quality systems including deviations, CAPA, document change and process change procedures, ensuring required procedures are followed
  • Compiling batch documentation for lot release in a timely manner per review and release schedule.
  • Ensuring all associated events are investigated and closed prior to lot release
  • Preparing responses for customer review observations
  • Working with minimal supervision
  • Providing ongoing cGMP Manufacturing review training
  • Training new members of Lot Review
  • Assessment of potential impact to product quality for open deviations during lot release Approval of minor events, as required
  • Providing back room support during regulatory audits

Qualifications:

  • Bachelor's Degree in Science related field with mid-entry level expeirence working in a GMP Environment
  • Excellent written and verbal communication skills
  • Must have attention to detail and good investigation, problem solving and organizational skills
  • Ability to work effectively with people and communicate negative information and obtain positive results
  • Works well and facilitates positive interdepartmental interactions with a diverse group of people. Voluntarily communicates needs and suggestions clearly and effectively. Listens and is attentive to others.
  • Familiarity with SAP, Trackwise, DMS, and LIMS systems an advantage
  • Completes assigned tasks on-time. Capable of being flexible as required tasks change and maintain productivity.
  • Keeps project leads and team members informed of the status of assigned work
  • Must be a strong, dependable team player
  • Ability to work with Microsoft Office applications
  • Resolve differing perspectives with effective negotiation skills
  • Properly prioritize tasks, manage time effectively. Positive proactive approach to drive projects to completion
  • Understands biopharmaceutical manufacturing environment working knowledge in cell culture, protein purification, lab processes and validation
  • Ability to interpret and apply current GMP regulations consistently
  • Ability to tolerate long hours of desk work

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status or any other characteristic protected by law.

 

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

 

Lonza.  The place to Go, Stay and Grow.







Posted: 2019-04-29 Expires: 2019-05-28
Sponsored by:
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Sponsored by:
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QA Lot Review Specialist

US06 Arch Chemicals Inc
Rochester, NY 14614

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