Supervisor I / II / III / Sr., Quality, QA

Location: 

NC-Clayton, US

Contract Type:  Regular Full-Time
Area:  Quality
Req Id:  409927

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Job Description:

The Quality Assurance Supervisor II/III/Sr. in the QA Fractionation business unit is primarily responsible for supervising or overseeing a group of employees performing tasks and assignments, including pre-pooling release of plasma pool shipments, assessment of plasma post donation & lookback alerts, preparation of pool sample shipments to the PEI and/or UK, and manufacturing record review for Pooling through Fractionation Batch Release to support department cycle time goals.  He/She participates in employee relations matters and is responsible for performance management in area of responsibility.  The Quality Assurance Supervisor II/III/Sr.  is a fully qualified professional who requires minimal supervision and is responsible for performing tasks and making decisions related to multiple Quality Systems, and developing and implementing solutions to a variety of Quality related issues or objectives.  He/she may also participate on cross-functional teams of varying scope and provide leadership and guidance to others.

 

Responsibilities include:

  • Ensure compliance with company policies and procedures and optimum use of staff and technical capabilities within defined areas.
  • Provide technical / non-technical expertise on quality related matters.
  • Provide guidance and consultation with manufacturing on GXP matters. 
  • Follow cGMP and department safety practices.
  • Provide effective leadership to employees in Quality.
  • Demonstrate high levels of values and integrity.
  • Consult with Quality Management, when necessary, regarding key decisions which need to be made within his/her defined area of responsibility.
  • Prepares and reviews SOP revisions, technical reports in DCM, failure investigations, and sampling/testing/data records
  • Make sound quality decisions with minimal guidance
  • Represent Quality at meetings

 

Additional responsibilities may also include:

  • Facilitate technical and non-technical training for other employees
  • Perform advanced roles (such as author, reviewer, approver, or coordinator) in all Quality Systems such as Change Control, Discrepancy Management, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews
  • Provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions. 
  • Interact with Senior members of management and/or regulatory officials
  • Make Quality related decisions that influence the direction of complex projects and lead project teams

 

Some tasks will be performed in a gowned, classified area including in +5°C or colder environments.

 

Requirements:

Candidates for the Supervisor II-QA must have a BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 5 years relevant experience, or equivalent combination of education and experience.

 

Candidates for the Supervisor III-QA must have a 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.

 

Candidates for the Sr. Supervisor-QA must have a BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 8 years relevant experience.  A minimum of a BS/BA is required.

 

Relevant experience must include:

  • Performing an advanced, independent role (such as author, reviewer, coordinator and/or approver) for multiple Quality System functions such as Change Control, Discrepancy Management, Batch Release, SAP, SAP Quality Module, Documentation, Annual Product Reviews, Risk Assessments and CAPA.
  • Review and/or approval of others’ work such as batch records, investigation reports, ETPs, validation protocols, etc.
  • Demonstrate consistent application of their technical expertise as well as the use of various technical reference materials such as BPRs, SOPs, CFRs, cGMP, FDA & EU Regulatory Guidance Documents  
  • Ability to be flexible and adapt to sudden changes in priorities and deadlines, multi-task, and work well under time constraints. 
  • Ability to make sound quality decisions with minimal guidance.
  • Demonstrate high levels of value, integrity, and attention to detail.
  • Excellent communication skills (written and verbal)

 

Preference will be given to candidates with knowledge of plasma receiving, pooling, fractionation, and associated manufacturing processes. 

 

Occupational Demands:

Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms.  Exposure to electrical office equipment. Exposure to extreme cold below 32*, miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on production floor. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists.  Occasionally walks. Often performs duties standing. Frequently bends and twists neck and waist.  Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frequently drives to other facilities.  Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences.  Frequently interacts with others, relates sensitive information to diverse groups.

 

EEO/Minorities/Females/Disability/Veterans

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

 

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