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Patheon
Scientist, QC Analytical (deviation writer)
St. Louis, MO - USA
Posted April 10, 2017

Join us as We Transform How Pharmaceuticals are Made.

Patheon is looking for people who are passionate about making a difference in people’s lives. Patheon is in need of proven leaders to nurture talent, build effective teams and drive engagement in an environment where people are motivated to do their best for the company, its clients and their patients. To inspire collaboration and innovation.
Summary

Summary:

Supports internal development and/or manufacturing operations. Analyzes, resolves issues, documents, and communicates test results. Specializes in maintaining QC Quality Systems such as deviations, non-conformances, out-of-specifications investigations, CAPA, change control, etc.

Key Requirements

Essential Functions:

  1. Provide quality control support in the development and maintenance of facility’s quality systems and procedures.
  2. Author and review Out-of-Specifications, Non-Conformances and deviations
  3. Report, analyze, and work with other departments to resolve material non-conformances.
  4. Drive completion of corrective actions and assess action effectiveness.
  5. Develop specifications, test methods, sampling plans and related written procedures.
  6. Review equipment, method, and process validation protocols and reports for compliance with cGMP requirements and FDA guidances.
  7. Develop and conduct training programs regarding company quality systems.
  8. Review and approve Change Control involving product or process changes.
  9. Conduct quality audits and develop and assess subsequent corrective action recommendation.
  10. Provide support in the rapid resolution of product complaints and/or safety issues.
  11. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.

Qualifications

Education:

Bachelor’s degree in physical science, preferably in Chemistry or Biology. Master's degree in Chemistry or Biology preferred.


Experience:

  • 3+ years of experience performing tests or analyses for pharmaceutical raw materials, finished products, or microbiological samples.
  • 1-3 years of technical writing experience

Competencies:

  • Knowledge and understanding of chemistry and analytical technologies.
  • Excellent understanding of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and chemistry.
  • Advanced problem solving skills and logical approach to solving scientific problems.
  • Excellent interpersonal and communication skills (both oral and written).
  • Expert presentation skills to present information to customers, clients, and other employees.
  • Ability to read, analyze, and interpret technical procedures and governmental regulations.
  • Ability to write standard operating procedures and policy manuals.
  • Ability to respond to complex inquiries or complaints from customers or regulatory agencies.
  • Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance, and correlation techniques.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.


Help Us Make a Healthier World.

Patheon provides development and manufacturing services for more than 800 pharmaceuticals, including nearly a fifth of the world’s top selling drugs. We’ve helped our clients earn more than twice as many U.S. FDA approvals than any other CDMO. Are you as committed as we are to exceeding expectations with high-quality solutions to complex problems? If so, we want to talk to you about making a healthier world... together. Join us at patheon.com
Disclaimer

Patheon is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

 

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