- Location:
- Frederick - NON SALES, MD 21703
- Status:
- Full Time, Employee
- Job Category:
- Biotech/R&D/Science
QA Specialist III - Raw Materials
Title: QA Specialist III - Raw Materials
Location: MD Frederick
Req: 02096
Position Summary:
Responsible for assuring the raw material quality for licensed or clinical products manufactured at MedImmune. The QA Raw Material Specialist III supports and provides advice to a number of functional areas including Manufacturing Development Quality Control (QC) Supply Chain Operations (SCO) Sourcing Purchasing and other Quality departments. Interprets and implements quality procedures manages raw material dispositions and assists in facilitating regulatory compliance inspections. Manages the review and implementation of Supplier Initiated Changes impacting FMC and site quality systems. Assists in the Site Self Inspection Program and Supplier Audit Program. Reviews documents such as SOPs deviations material number requests corrective and preventive action plans QC protocols/reports technical reports etc. that are submitted to QA for approval. May assist in supervision on activities of other QA Specialists.
Job Functions:
1. Utilizes the QA system to assure compliance with cGMP regulations.
2. Works closely with QC and Development to facilitate the development and implementation of appropriate material specifications throughout the raw material life cycle from clinical to manufacturing requirements.
3. Assists in the administration review and approval of Change Control Documents Deviations and CAPAs for assigned materials as required.
4. Supports the evaluation and disposition of raw materials through timely compliance evaluation of material batch files laboratory results and other cGMP documents.
5. Manages workflow to assure the timely supply of raw materials to commercial and clinical products. Employs metrics to identify and communicate potential schedule adherence issues and works towards their resolution.
6. Contacts suppliers as needed to address material concerns assist in the implementation of SICs and to provide appropriate support for the Supplier Audit Program
7. Facilitates conference calls with appropriate Medi personnel and suppliers as needed.
8. Creates and Coordinates appropriate trainings to facilitate the understanding of the raw material process company wide.
9. Serves as a QA representative for project teams. May assist in the management of small to medium sized projects impacting the QA department.
10. Investigates and assesses the impact of minor and major deviations that may pertain to raw material releases. Identifies root causes and recommends/implements corrective /prevent actions to avoid recurrence.
11. Reviews QC method protocols.
12. Supports other groups to complete annual product reviews.
13. Serves as a lead auditor for the Site Self Inspection Program and assists in the preparation execution and follow up activities related to Supplier Audits
14. Provides leadership and guidance to peers in the QA department and functional areas.
15. May assist in the supervision in the activities of other QA personnel.
16. Using appropriate OE tools identifies and implements improvements to processes in order to enhance compliance cost reductions and efficiencies.
Physical Demands:
Noise level: Quiet
Vision Requirements: Ability To Adjust Focus
Lifting Limits: Up to 50 lbs
Work Environment:
Percentage of Time:
Standing: 25-45%
Walking: 20-40%
Sitting: 26-50%
Talking and Hearing: 76-100%
Working With Fumes And Air Born Particles: 0 - 25%
Working With Toxic or Caustic Chemicals: 0 - 25%
Knowledge:
Complete understanding and wide application of regulation guidelines principles theories and concepts in the field. General knowledge of supplier audits sourcing supply chain and other related disciplines as needed.
Technical Knowledge:
GMP's Database knowledge deviation investigations root cause corrective actions
trend analysis
Problem Solving:
Provides compliant solutions to a wide range of difficult problems relating to raw materials. Solutions are imaginative thorough practicable and consistent with organizational objectives.
Discretion / Latitude:
Works under only general direction. Executes deliverables in a timely manner with little to no oversight. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
Impact:
Contributes to the completion of specific programs and projects. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
Liaison:
Frequent inter-organizational and outside supplier contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.
Educations:
Typical Education:
Bachelors: Life Sciences
Typical Experience:
5-7 years experience
Certificates Licenses Registrations:
N/A
CLICK HERE TO APPLY
MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
Location: MD Frederick
Req: 02096
Position Summary:
Responsible for assuring the raw material quality for licensed or clinical products manufactured at MedImmune. The QA Raw Material Specialist III supports and provides advice to a number of functional areas including Manufacturing Development Quality Control (QC) Supply Chain Operations (SCO) Sourcing Purchasing and other Quality departments. Interprets and implements quality procedures manages raw material dispositions and assists in facilitating regulatory compliance inspections. Manages the review and implementation of Supplier Initiated Changes impacting FMC and site quality systems. Assists in the Site Self Inspection Program and Supplier Audit Program. Reviews documents such as SOPs deviations material number requests corrective and preventive action plans QC protocols/reports technical reports etc. that are submitted to QA for approval. May assist in supervision on activities of other QA Specialists.
Job Functions:
1. Utilizes the QA system to assure compliance with cGMP regulations.
2. Works closely with QC and Development to facilitate the development and implementation of appropriate material specifications throughout the raw material life cycle from clinical to manufacturing requirements.
3. Assists in the administration review and approval of Change Control Documents Deviations and CAPAs for assigned materials as required.
4. Supports the evaluation and disposition of raw materials through timely compliance evaluation of material batch files laboratory results and other cGMP documents.
5. Manages workflow to assure the timely supply of raw materials to commercial and clinical products. Employs metrics to identify and communicate potential schedule adherence issues and works towards their resolution.
6. Contacts suppliers as needed to address material concerns assist in the implementation of SICs and to provide appropriate support for the Supplier Audit Program
7. Facilitates conference calls with appropriate Medi personnel and suppliers as needed.
8. Creates and Coordinates appropriate trainings to facilitate the understanding of the raw material process company wide.
9. Serves as a QA representative for project teams. May assist in the management of small to medium sized projects impacting the QA department.
10. Investigates and assesses the impact of minor and major deviations that may pertain to raw material releases. Identifies root causes and recommends/implements corrective /prevent actions to avoid recurrence.
11. Reviews QC method protocols.
12. Supports other groups to complete annual product reviews.
13. Serves as a lead auditor for the Site Self Inspection Program and assists in the preparation execution and follow up activities related to Supplier Audits
14. Provides leadership and guidance to peers in the QA department and functional areas.
15. May assist in the supervision in the activities of other QA personnel.
16. Using appropriate OE tools identifies and implements improvements to processes in order to enhance compliance cost reductions and efficiencies.
Physical Demands:
Noise level: Quiet
Vision Requirements: Ability To Adjust Focus
Lifting Limits: Up to 50 lbs
Work Environment:
Percentage of Time:
Standing: 25-45%
Walking: 20-40%
Sitting: 26-50%
Talking and Hearing: 76-100%
Working With Fumes And Air Born Particles: 0 - 25%
Working With Toxic or Caustic Chemicals: 0 - 25%
Knowledge:
Complete understanding and wide application of regulation guidelines principles theories and concepts in the field. General knowledge of supplier audits sourcing supply chain and other related disciplines as needed.
Technical Knowledge:
GMP's Database knowledge deviation investigations root cause corrective actions
trend analysis
Problem Solving:
Provides compliant solutions to a wide range of difficult problems relating to raw materials. Solutions are imaginative thorough practicable and consistent with organizational objectives.
Discretion / Latitude:
Works under only general direction. Executes deliverables in a timely manner with little to no oversight. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
Impact:
Contributes to the completion of specific programs and projects. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
Liaison:
Frequent inter-organizational and outside supplier contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.
Educations:
Typical Education:
Bachelors: Life Sciences
Typical Experience:
5-7 years experience
Certificates Licenses Registrations:
N/A
CLICK HERE TO APPLY
MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
