Address
Form of workSPECIFIC POSITION DUTIES (RESPONSIBILITIES, TASKS, ESSENTIAL FUNCTIONS)
1. Works collaboratively with Manufacturing, Technical Operations, Quality Control and Regulatory Affairs, as well as CMO sites to ensure compliance with CMC controls, specifications, regulations, and Quality technical agreements.
2. Provides QA operations oversite and support for internal/external manufacturing operations including review and approval of protocols and reports, master batch records, executed batch records and QC data verifications under management guidance.
3. Coordinates, prepares and approves the release process documentation for LFB products including IP1, Drug Substance and Drug Products with management guidance.
4. Assists with the management of deviations, change controls, corrective and preventive actions for operations: Provides support for Lot release activities and Management Reviews.
5. With management guidance interfaces Works collaboratively with Quality Control to assist to resolve quality system issues, compliance needs, OOS investigations, environmental excursions, and assay validation needs.
6. Provides support as needed in the following capacity: review of technical input on investigations, deviation, non-conformances, and change controls.
7. Supports continuous improvement quality initiatives to be inspection ready.
8. Active involvement in support of cGMP inspections from regulatory authorities.
9. Effectively participates in Quality Assurance system process improvements and associated training as needed.
10. Compiles and summarizes necessary information monthly in support of Annual Product Reviews, Product Quality Reviews and Annual Reports at LFB. 11. Other duties as assigned:
• Prepare and review Manufacturing Production Records (MPRs) and associated labels
• Aid in revisions of documents, training modules, and MPRs
• Review of FVII qualification records, sample paperwork, and QC Assays
• Scanning and filing of documents
• Release of GMP Materials
• Review of Blue Mountain Building Management System and other quality system records
POSITION QUALIFICATIONS (EDUCATION, EXPERIENCE, KNOWLEDGE, PHYSICAL REQUIREMENTS)
- Requires a Bachelor's degree with more than 2 years of experience working in a FDA/EMA regulated environment with an understanding of cGMP compliance, manufacturing and quality laboratory operations.
- Must be able to communicate effectively (verbal/written) to multiple disciplines and levels within an organization.
- Ability to adjust to changing environment, setting priorities for self and be self-motivated. should be able to function independently or within a team with minimal direct supervision.
ROLE EXPECTATIONS (Overall expectations for role level - Operations Specialist I
Defines a plan to achieve stated objectives:
Scope: With input from peers and/or management, establishes objectives. Management reviews objectives to determine success.
Complexity: Assures adherence to budgets, schedules, work plans, and performance requirements.
Impact: Erroneous decisions or failure to achieve results will add to costs and may impact the short-term goals of the organization.
Interaction: Regularly interacts with management from a variety of organizational areas. Displays the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.
Supervision: Reports to QA Operations management. Serves as a member of a Quality team as an individual contributor working in close association with a variety of QA/QC and manufacturing/operations peers. Assist the Quality team in the development and execution of quality compliance goals and objectives for internal and external programs.
1. Works collaboratively with Manufacturing, Technical Operations, Quality Control and Regulatory Affairs, as well as CMO sites to ensure compliance with CMC controls, specifications, regulations, and Quality technical agreements.
2. Provides QA operations oversite and support for internal/external manufacturing operations including review and approval of protocols and reports, master batch records, executed batch records and QC data verifications under management guidance.
3. Coordinates, prepares and approves the release process documentation for LFB products including IP1, Drug Substance and Drug Products with management guidance.
4. Assists with the management of deviations, change controls, corrective and preventive actions for operations: Provides support for Lot release activities and Management Reviews.
5. With management guidance interfaces Works collaboratively with Quality Control to assist to resolve quality system issues, compliance needs, OOS investigations, environmental excursions, and assay validation needs.
6. Provides support as needed in the following capacity: review of technical input on investigations, deviation, non-conformances, and change controls.
7. Supports continuous improvement quality initiatives to be inspection ready.
8. Active involvement in support of cGMP inspections from regulatory authorities.
9. Effectively participates in Quality Assurance system process improvements and associated training as needed.
10. Compiles and summarizes necessary information monthly in support of Annual Product Reviews, Product Quality Reviews and Annual Reports at LFB. 11. Other duties as assigned:
• Prepare and review Manufacturing Production Records (MPRs) and associated labels
• Aid in revisions of documents, training modules, and MPRs
• Review of FVII qualification records, sample paperwork, and QC Assays
• Scanning and filing of documents
• Release of GMP Materials
• Review of Blue Mountain Building Management System and other quality system records
POSITION QUALIFICATIONS (EDUCATION, EXPERIENCE, KNOWLEDGE, PHYSICAL REQUIREMENTS)
- Requires a Bachelor's degree with more than 2 years of experience working in a FDA/EMA regulated environment with an understanding of cGMP compliance, manufacturing and quality laboratory operations.
- Must be able to communicate effectively (verbal/written) to multiple disciplines and levels within an organization.
- Ability to adjust to changing environment, setting priorities for self and be self-motivated. should be able to function independently or within a team with minimal direct supervision.
ROLE EXPECTATIONS (Overall expectations for role level - Operations Specialist I
Defines a plan to achieve stated objectives:
Scope: With input from peers and/or management, establishes objectives. Management reviews objectives to determine success.
Complexity: Assures adherence to budgets, schedules, work plans, and performance requirements.
Impact: Erroneous decisions or failure to achieve results will add to costs and may impact the short-term goals of the organization.
Interaction: Regularly interacts with management from a variety of organizational areas. Displays the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.
Supervision: Reports to QA Operations management. Serves as a member of a Quality team as an individual contributor working in close association with a variety of QA/QC and manufacturing/operations peers. Assist the Quality team in the development and execution of quality compliance goals and objectives for internal and external programs.
