QA Supervisor II/III, QA Release

Location: 

NC-Clayton, US

Contract Type:  Regular Full-Time
Area:  Quality
Req Id:  511141

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

QA Release Supervisor II, III

 

Supervisor II, QA:

The Supervisor II, Quality Assurance is responsible for supervising or overseeing a group of employees or a Quality Assurance system, program, project, etc. Participates in employee relations matters and is responsible for performance management in area of responsibility.  May occasionally represent quality in meetings.  Specific duties will depend on the assignment and may include review of manufacturing or testing records, preparation or review of failure investigations, sampling/testing/data analysis, auditing, data analysis for stability, etc.  (i.e. Documentation review, product investigations, product release, internal and external audit support, materials clearance, etc.). The incumbent is an established and technically competent professional who develops and implements solutions to a variety of quality related objectives.  He/she may participate on teams or projects of varying scope and is often called upon by peers for his/her expertise or guidance. Demonstrates consistent application of technical knowledge and expertise, executes assignments of medium complexity, developing solutions for defined problems.  The employee is responsible for training other employees. 

 

Primary responsibilities for Supervisor II, QA role:

  • Supervise or oversee all aspects of a group of employees and/or a Quality system, program, or project.
  • Ensures compliance with company policies and procedures and is responsible for optimum use of staff and technical capabilities within defined areas.
  • Provides technical / non-technical expertise on quality related matters.
  • Provides guidance or may consult with manufacturing and internal regulatory departments on Quality matters. 
  • Follows cgmp and department safety practices.
  • Provides effective leadership to employees in Quality.
  • Demonstrates high levels of value and integrity.
  • May consult with Quality Management regarding key decisions which need to be made within his/her defined area of responsibility.
  • Demonstrated ability to make sound quality decisions with minimal guidance
  • Prepares and reviews SOP revisions, technical reports in DCM, and Change Control Requests
  • Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.
     

Additional Responsibilities:

  • Responsibilities may include roles (such as author, reviewer, administrator or coordinator) in all quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, etps, and Regulatory submissions.  Responsible for representing Quality at business unit meetings, and project meetings.

 
Supervisor III, QA:
Responsible for supervising or overseeing a group of employees or a Quality Assurance system, program, project, etc. Participates in employee relations matters and is responsible for performance management in area of responsibility.  May facilitate technical and non-technical training.  Responsibilities may also include advanced roles (such as author, reviewer, approver, administrator or coordinator) in all quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, etps, and Regulatory submissions.  Responsible for representing Quality meetings. The employee may be responsible for training or supervising other employees and is a fully qualified professional who requires minimal supervision.  

 

Primary responsibilities for Supervisor III, QA role:

  • Supervise or oversee all aspects of a group of employees and/or a Quality system, program, or project.     
  • Ensures compliance with company policies and procedures and is responsible for optimum use of staff and technical capabilities within defined areas.                                                                            
  • Provides technical / non-technical expertise on quality related matters.                   
  • Provides guidance or may consult with manufacturing and internal regulatory departments on GXP matters.                                                                                 
  • Follows cgmp and department safety practices.                                                                 
  • Provides effective leadership to employees in Quality.                                                                     
  • Demonstrates high levels of values and integrity.                                                               
  • May consult with Quality Management regarding key decisions which need to be made within his/her defined area of responsibility.                                                                    
  • Demonstrated ability to make sound quality decisions with minimal guidance                                        
  • Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.
     

Additional Responsibilities :

  • Responsibilities may include roles (such as author, reviewer, administrator or coordinator) in all quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, etps, and Regulatory submissions.  Responsible for representing Quality meetings.

 
 

Knowledge, Skills, Abilities for all levels:  
Excellent communication skills (written and verbal) with familiarity of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines. 
 
Education/Experience requirements: 
 
QA Release Supervisor II:
BS/BA preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 5 years relevant experience, or equivalent combination of education and experience
 
QA Release Supervisor III:
BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 6 years relevant experience, or equivalent combination of education and experience.
 

 

 

 

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

 

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law.  We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

 

Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton 

 

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