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Project Manager, Quality Control

Date: Apr 6, 2021

Location: Lafayette, IN, US

Company: Evonik Industries AG

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VACANCY REFERENCE NUMBER 141261
 

Project Manager, Quality Control

 

Location: United States : Lafayette, IN

Function: Innovation Management (R&D)

Career Level: Experienced professionals (2-5 years)

Legal Entity: Evonik Corporation

Business Line: Health Care

 

What we offer

You will work on exciting and challenging topics together with a team in an ultra-modern, innovative and creative environment. Intensive on-the-job training with expert colleagues guarantees you will quickly become familiar with your duties and perform them independently. Performance related pay and the opportunity for personal and professional development are of course part of the package. Since 2009 Evonik Industries AG has been certified as a family-friendly company by the German Hertie Foundation.

Click here to learn more about Evonik from our employees

The Project Manager, QC, will be expected to interface with customers to define the requirements for new projects and will serve as a Project Lead for laboratory activities necessary for introduction of new products into the lab. This position is responsible for providing complete technical oversight to the Quality Control Laboratories. The role is responsible for ensuring appropriate review and approval of all types of analytical data (e.g., laboratory testing, protocols, changes, methods, etc). This includes responsibility for assuring that API materials (and some intermediates) for non-commercial products have met all analytical testing criteria prior to being shipped off site. This person will also be responsible for introducing new technologies, products or methods, and coaching/mentoring of Quality Control Laboratory personnel. Responsibilities include leading internal projects or customer initiated projects and influencing improvements or initiatives across this site.
The Project Manager, QC, may participate in regulatory agency and customer inspections, and will develop and deliver protocol-driven studies (e.g., method development, method validations, investigational studies, method transfers). This person will provide analytical support as necessary to ensure that all new project related activities are executed as specified in the overall project plan. This includes the execution of protocol-driven studies and ownership of activities required to implement new customer methods.

 

RESPONSIBILITIES

Technical

  • Key contact with Research, Development, and Innovation (RDI)  Project Manager and customers during new process implementation of analytical specifications and methodology. Works with team to determine method implementation strategies (validation, verification, etc.) and works with chemists to schedule method implementation activities.
  • Creates all analytical method protocols related to method validation, verification, and transfer for assigned projects.
  • Provides complete technical oversight to Quality Control and has knowledge of most analytical techniques utilized throughout the lab.
  • Has significant technical expertise in at least one technology of relevance to the lab.
  • Supports analytical investigations and deviations (e.g. OOS, stability failure, suspect results, FRCC, protocol failure,etc.
  • Reviews and approves all types of analytical data including protocols, methods, and data supporting the release of material from the site.

Customer and Offsite Evonik Interaction

  • Can routinely interact with customer technical resources to define the requirements for new projects. May be able to provide back-up support to the QC Management for routine customer interactions in the absence of the QC Management.

Teamwork & Interpersonal

  • Collaborates/coordinates activities within the area and sometimes outside the area Leads teams by directing the day to day work of others within the department. Participates in training others.
  • Provides coaching and mentoring to Quality Control Laboratories personnel (e.g., technical issues, root cause analysis, investigation techniques).

Influence

  • Technical resource for analytical questions in Quality Control and recognized as technical expert in at least one technology of relevance to Quality Control.
  • Participates in projects and will serve as a Project Lead within Quality Control.

Communication

  • Demonstrates technical competence through oral or written communications within project team and customers as needed.

Self Management

  • Complies with safety, quality, and operating procedures.
  • Self-motivated, prioritizes and plans own work, and sometimes plans work on projects involving others.   
  • Effectively completes multiple complex tasks.
  • Makes improvements in own efficiency and positively influences efficiency of others.

Innovation 

  • Reviews scientific literature and looks to introduce new technologies in Quality Control Identifies opportunities for operational or efficiency improvements and delivers solutions to these opportunities.

Quality
Each individual is responsible to meet fundamental cGMP requirements relating to their conduct and work practices to ensure the quality of the products manufactured at Evonik Tippecanoe Laboratories. This includes but is not limited to the following:

  • Adherence to all written instructions.
  • Timely reporting of all deviations to supervision.
  • Training on each activity is completed and current and that each employee understands their assigned duties.
  • Strict documentation practices are followed to ensure that all steps of the operation are appropriately documented.
  • Ensure to maintain the work area in a state of cleanliness and sanitation through good housekeeping practices and applying good personal health practices.
  • Ensure the security and safety of the product through the reporting of any potential risk to supervision immediately.
  • Ensure the safety of the personnel and product by wearing proper PPE (Personal Protective Equipment) according to the operation being executed.
  • Each individual should report any action that they believe could impact the SISPQ of any product immediately to supervision.

Environmental, Safety, Health, & Security (ESHS) Adhere to ESHS programs, rules, & procedures.

  • Assume personal accountability for individual behaviors related to ESHS activities.
  • Have the appropriate knowledge and tools prior to performing a task.
  • Complete all required ESHS training and remain current with applicable learning plans at all times.
  • Report all injuries to Employee Health Services or Security and supervision within the same shift of the incident occurring.
  • Inform direct supervision of any ESHS hazards or concerns in the workplace.
  • Provide feedback and coaching to coworkers on both safe and unsafe behaviors and conditions. Actively participate in the ESHS management system as directed by supervision.
     

 

 

REQUIREMENTS

  • Minimum BS, in a scientific field - Chemistry preferred.
  • Relevant laboratory experience in a regulated environment, 5+ years of experience.
  • Fundamental understanding of analytical chemistry.
  • Project management experience.
  • Demonstrated laboratory skills and technical expertise.
  • Ability to work non-core hours to support 24/7 mfg operations.
  • Proficient at the use of MS Office, specifically Word and Excel.
  • Great teamwork/Interpersonal skills.
  • Ability to manage multiple projects efficiently.
  • Understanding of method validation.
  • Ability and desire to complete laboratory testing/method validation (HPLC, GC, etc).
  • Capability to perform independent laboratory work.
  • Pharma Industry or CMO experience preferred.
  • QC lab experience preferred.
  • Analytical chemistry experience preferred.
  • Experience with HPLC and GC preferred.
 

Your Application

To ensure the fastest process of your application and to protect the environment, please apply online via our careers portal at https://careers.evonik.com.

VACANCY REFERENCE NUMBER 141261

Evonik Corporation is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, gender, sexual orientation, national origin, disability status, protected veteran status or any other legally protected status.

Please note that Evonik will not accept any unsolicited application documents sent by staffing firms. Evonik works in conjunction with preferred service providers and will not pay any fee to staffing firms in the absence of an appropriate framework agreement. Should Evonik receive a candidate profile from a staffing firm with which it has no framework agreement, and should this candidate subsequently be considered in the recruitment process or offered employment, no claims from the staffing firm will be entertained in this regard.
 


Nearest Major Market: Lafayette