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Manager, Quality Control

Job Category:  Quality
Work Location:  Corbion Site
Office Location: 

Tucker, GA, US

Job Type:  Full Time
Job ID:  773

Corbion develops sustainable solutions to improve the quality of life for people today and for future generations.

 

Corbion (formerly known as Purac Biomaterials) is the market leader in providing high quality resorbable polymers in the field of medical devices and pharmaceutical applications. These resorbable polymers are used in orthopedic implants, drug delivery systems and surgical suture applications among others. Corbion is now hiring a QC Manager to join the company in its manufacturing facility in Tucker, GA, USA.

 

Position Summary

 

The Quality Control (QC) Manager's main job objective  is to lead the QC department with the primary goal of maintaining a cGMP compliant laboratory while providing a fast and reliable analytical process control for raw materials, intermediates, and finished products to internal and external clients.  You will ensure quality to external clients within established lead times and on budget.  You will also release product to the market, in consultation with Quality Assurance.

 

As our  QC Manager  you will be responsible for reviewing data in a timely, accurate, and precise manner from Quality Control Analysts.  You will oversee the maintenance of all calibrations and preventative maintenance in the Quality Control Laboratory according to cGMP. These objectives are keys to success for the position in the fast-paced and rapidly growing business environment.  You will ensure that data in the laboratory is in compliance with cGMP, customer quality agreements, and external regulatory agencies.

 

Additionally, you will support internal and external audits including customer quality compliance audits and agency cGMP compliance  in addition to helping to resolve or address any corrective actions that may need to take place.  You will monitor training for current and new QC Analysts, participate in continuous improvement activities and work with Process Control to represent Quality for process improvement initiatives.

 

This position reports to the Director Quality & Regulatory Affairs of Biomaterials at Tucker, Georgia.

 

Responsibilities:

  • Lead and manage the QC department with respect to:
    • Employees (team leadership, scheduling, empowerment, development, accountability, training, and coaching)
    • International operating procedures, validated according to GMP regulations
    • Analytical developments
  • Perform method validation, work with technical team to evaluate instruments and make decisions on design and development of experiments, processes, and methods to evaluate product lines.
  • Stay informed of all global change control and documentation from Netherlands for Biomaterials.
  • Product Disposition:
    • Approval of raw materials, intermediates, semi-finished products, and finished goods in compliance with cGMP and in conjunction with QA
    • Ensure all QC activities are in compliance to cGMP and ISO 9001 and customer requirements
    • Manage development and validation of new analytical methods and instruments for innovation products and analytical support to production, projects for New Business Development purposes

 

Minimum Qualifications:

  • Bachelors of Science in Chemistry, Biology, Chemical Engineering, Life Sciences or the equivalent, advanced degree is a plus.
  • 10+ years analytical experience with chemical instrumental method development, validation and statistics.  Experience in testing polymers is beneficial.
  • 5+ years’ experience with Quality systems (cGMP, ISO, ICH Q7, cGLP) and pharmaceutical and medical devices.
  • 3+ years’ management experience.
  • Must have technical writing capability and be subject matter expert with validations and qualifications..
  • Must have experience in reviewing documentation in cGMP environment.
  • Experience working with regulatory agencies, including FDA audits and filings.
  • Knowledge of FDA 21 CFR 820, 21 CFR 210/211, ICH Q7, ISO 13485, cGMPs .
  • Must know the tests that the laboratory performs and be able to troubleshoot testing deviations. 
  • Experience in a related industry laboratory environment; atomic absorption, gas-liquid chromatography, HPLC or near-infrared spectrophotometry beneficial, Inherent Viscosity (IV), Residual Solvent Testing, and Gel Permeation (GPC).
  • Must be able to write SOPs that are related to Quality Control Testing.
  • Exceptional computer skills required.
  • Possesses good communication and writing skills and be able to work effectively with all levels of individuals within the organization
  • Able to stand for extended durations  of time needed to perform testing.
  • Capable of operating all equipment in the laboratory. 

 

About Corbion

Corbion is the global market leader in lactic acid, lactic acid derivatives, and a leading company in emulsifiers, functional enzyme blends, minerals, vitamins and algae ingredients. Our sustainable ingredient solutions help differentiate products in markets such as food, home & personal care, animal nutrition, pharmaceuticals, medical devices, and bioplastics. With a worldwide network of production facilities, sales offices and agents in more than 100 countries, Corbion is known for quality, product innovation, and customer orientation, as well as for its collegial, informal and results-oriented company culture.

 

Corbion is an equal opportunity employer and committed to a diverse workplace.  All applicants will be considered equally without regard to race, color, ethnicity, veteran status, religion, national origin, marital status, political affiliation, age, sex, sexual orientation, handicapping condition, membership in an organization or any other non-merit factors.

 

Corbion provides reasonable accommodation to applicants with disabilities.  If you need a reasonable accommodation for any part of the application and hiring process, please notify the Corbion Human Resources department.  The decision on granting reasonable accommodation will be on a case-by-case basis.

 

EOE/M/F/Vet/Disabled

 

Corbion does not accept unsolicited resumes from individual recruiters or third party recruiting agencies in response to job postings. No fee will be paid to third parties who submit unsolicited candidates directly to our hiring managers. All candidates must be submitted by approved Corbion vendors who have been expressly requested to make a submission by our Talent Acquisition team for a specific job opening. No placement fees will be paid to any firm unless such a request has been made by the Corbion Talent Acquisition team and such candidate was submitted to the Corbion Talent Acquisition Team.


Nearest Major Market: Atlanta

Job Segment: Orthopedic, Medical, Engineer, Chemical Research, Quality, Healthcare, Engineering

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