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QA Specialist III, CMO Quality Operations
Job Description
QA Specialist III, CMO Quality Operations
Potential for some hybrid flexibility but onsite about 4 days per week.
Description
We are seeking a Quality Specialist III to join our Quality Assurance Operations team in Gaithersburg, MD. The specialist will be responsible for support of GMP compliance with
a focus on Manufacturing. The candidate will provide critical review, organization, and Quality oversight of records generated during GMP manufacturing, release and stability
testing of biotechnologically produced vaccines, as well as analytical records and data generated for studies conducted under GCLP and GLP guidelines/regulations. This
position will require periodic weekend/evening work and travel.
** Available for domestic and international travel, as required by the business. **
Summary of the Position:
The Contract Manufacturing Organization team is seeking a QA Specialist III to support the CMO Quality Team. You will evaluate and review clinical and/or commercial batches
for our vaccine's portfolio. You will make sure that product and manufacturing process records are within the specifications established and include complete information
relating to the production and control of each batch or finished product. As a QA Specialist III, you are responsible for Batch Record Review quality activities in
accordance with cGMPs, ax policies, standards, and procedures. You will also be responsible to work towards team and business goals.
Responsibilities include but are not limited to:
Review of quality records and data generated during the manufacturing and/or testing of vaccines for compliance to current Good Manufacturing Practices
(cGMP), Good Laboratory Practices (cGLP), Good Clinical Laboratory Practices (GCLP) and ax Standard Operating Procedures (SOPs) and protocols.
Records and data include, but are not limited to:
o cell banks records
o virus stocks records
o drug substance batch records
o drug product batch records
o other(s) related documentation
Review and approval of executed batch records.
Ensure all records and documentation related to the executed batch record(s) for completeness, accuracy, and compliance of cGMPs and ax SOPs.
Provide Quality support for resolution of deviations related to manufacturing activities and department. Maintain oversight of deviations within department.
Be aware of Change Controls impacting CMOs
Implement CAPAs as required
Maintain department metrics
Author and/or provide review and approval for generation of new or revised Quality SOPs and other controlled documentation. Author quality documents as
assigned
Represent the QA CMO/ CTL Management Team with cross functional project teams
Review and approval of manufacturing technology transfer, qualification, and validation documents internally and oversight activities to CMOs
Establish tracking system and proactively request batch records and disposition materials based on expected turnaround times and quality agreements.
Able to effectively multitask
Responsible to ensure appropriate escalation, communication channels are used to ensure senior management are kept informed of critical issues, as required
Management of critical issues and timely resolution, developing solutions to complex situations
Responsible for identifying risks and communicating gaps for GMP processes in a timely manner
Responsible to ensure on time execution of activities and team timeline adherence
Support health authority inspections as required
Perform SAP transactions as required
Facilitate continuous improvement projects and improves efficiency and productivity within the team
Ensure compliance by maintaining training completion on time and perform any other job-related duties as requested by management
Minimum requirements:
Bachelor's degree in science
Minimum of 3 years of GxP industry experience
Excellent understanding of Quality Assurance systems
Strong communication and organizational skills
Demonstrated ability to apply GMP, GLP, GCP and GCLP expectations
Knowledge of global regulatory expectations (including FDA and EMA).
The established recognition within QA as a technical expert
Requires completing routine and complex tasks with little or no supervision
Must be highly motivated, well organized, and detail-oriented person
Must be action-oriented and customer-focused and skilled in building relationships, problem solving, and planning
Must have strong ability to critically review investigations, results and provide technical conclusions consistent with Quality risk management principles
Preferred requirements:
Demonstrated knowledge in completing investigations and problem resolution
Demonstrated interest and ability to manage technical, operational, and
administrative aspects of the team
Demonstrated ability to apply GMP, GLP, GCP and GCLP expectations
The flexibility to strategize a new direction of his/her work when change is encountered or necessary; to help teammates with their own agility in a changing
context
The accountability to have others' confidence in achieving deliverables that are complex, requiring interaction with other members of the immediate team and
beyond
The ability to produce high-quality work on complex problems with cross [1] functional involvement; to anticipate and proactively prevent risks and
compromises to quality
The capability to recognize inefficiencies in the team and identifies improvements constructively; to work across teams effectively and frequently collaborate on
other business areas
Potential for some hybrid flexibility but onsite about 4 days per week.
Description
We are seeking a Quality Specialist III to join our Quality Assurance Operations team in Gaithersburg, MD. The specialist will be responsible for support of GMP compliance with
a focus on Manufacturing. The candidate will provide critical review, organization, and Quality oversight of records generated during GMP manufacturing, release and stability
testing of biotechnologically produced vaccines, as well as analytical records and data generated for studies conducted under GCLP and GLP guidelines/regulations. This
position will require periodic weekend/evening work and travel.
** Available for domestic and international travel, as required by the business. **
Summary of the Position:
The Contract Manufacturing Organization team is seeking a QA Specialist III to support the CMO Quality Team. You will evaluate and review clinical and/or commercial batches
for our vaccine's portfolio. You will make sure that product and manufacturing process records are within the specifications established and include complete information
relating to the production and control of each batch or finished product. As a QA Specialist III, you are responsible for Batch Record Review quality activities in
accordance with cGMPs, ax policies, standards, and procedures. You will also be responsible to work towards team and business goals.
Responsibilities include but are not limited to:
Review of quality records and data generated during the manufacturing and/or testing of vaccines for compliance to current Good Manufacturing Practices
(cGMP), Good Laboratory Practices (cGLP), Good Clinical Laboratory Practices (GCLP) and ax Standard Operating Procedures (SOPs) and protocols.
Records and data include, but are not limited to:
o cell banks records
o virus stocks records
o drug substance batch records
o drug product batch records
o other(s) related documentation
Review and approval of executed batch records.
Ensure all records and documentation related to the executed batch record(s) for completeness, accuracy, and compliance of cGMPs and ax SOPs.
Provide Quality support for resolution of deviations related to manufacturing activities and department. Maintain oversight of deviations within department.
Be aware of Change Controls impacting CMOs
Implement CAPAs as required
Maintain department metrics
Author and/or provide review and approval for generation of new or revised Quality SOPs and other controlled documentation. Author quality documents as
assigned
Represent the QA CMO/ CTL Management Team with cross functional project teams
Review and approval of manufacturing technology transfer, qualification, and validation documents internally and oversight activities to CMOs
Establish tracking system and proactively request batch records and disposition materials based on expected turnaround times and quality agreements.
Able to effectively multitask
Responsible to ensure appropriate escalation, communication channels are used to ensure senior management are kept informed of critical issues, as required
Management of critical issues and timely resolution, developing solutions to complex situations
Responsible for identifying risks and communicating gaps for GMP processes in a timely manner
Responsible to ensure on time execution of activities and team timeline adherence
Support health authority inspections as required
Perform SAP transactions as required
Facilitate continuous improvement projects and improves efficiency and productivity within the team
Ensure compliance by maintaining training completion on time and perform any other job-related duties as requested by management
Minimum requirements:
Bachelor's degree in science
Minimum of 3 years of GxP industry experience
Excellent understanding of Quality Assurance systems
Strong communication and organizational skills
Demonstrated ability to apply GMP, GLP, GCP and GCLP expectations
Knowledge of global regulatory expectations (including FDA and EMA).
The established recognition within QA as a technical expert
Requires completing routine and complex tasks with little or no supervision
Must be highly motivated, well organized, and detail-oriented person
Must be action-oriented and customer-focused and skilled in building relationships, problem solving, and planning
Must have strong ability to critically review investigations, results and provide technical conclusions consistent with Quality risk management principles
Preferred requirements:
Demonstrated knowledge in completing investigations and problem resolution
Demonstrated interest and ability to manage technical, operational, and
administrative aspects of the team
Demonstrated ability to apply GMP, GLP, GCP and GCLP expectations
The flexibility to strategize a new direction of his/her work when change is encountered or necessary; to help teammates with their own agility in a changing
context
The accountability to have others' confidence in achieving deliverables that are complex, requiring interaction with other members of the immediate team and
beyond
The ability to produce high-quality work on complex problems with cross [1] functional involvement; to anticipate and proactively prevent risks and
compromises to quality
The capability to recognize inefficiencies in the team and identifies improvements constructively; to work across teams effectively and frequently collaborate on
other business areas
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