Quality Consulting Group, LLC
Respnsibilities:
Initiate, revise, and approve manufacturing-controlled documents in the document management system.
Serve as document author, owner, reviewer, or data verifier as needed, ensuring all controlled documents accurately reflect current operations and compliance standards.
Implement new product introductions and major projects
within Drug Substance (DS) operations.
Collaborate with Capital and cross-functional teams to define requirements, develop operational strategies, and implement deliverables, including procedures, batch records, automation, materials, new equipment introduction/modifications, cleaning, changeover, process validation, training, and floor readiness.
Analyses floor operations data and observations to identify root causes of deviations or inefficiencies.
Develop and implement data-driven solutions to drive process improvements and enhance operational performance.
Ensure timely investigation and resolution of deviations within established goals.
Perform deviation assessments, support root cause analysis (RCA), human performance evaluations, and CAPA development.
Monitor CAPA effectiveness to prevent recurrence
and take additional corrective actions as needed.
Assist in the development and
execution of process validation protocols and reports.
Collect, analyze, and interpret process validation data to ensure compliance and operational robustness.
Lead or support change control initiatives, ensuring alignment with regulatory and operational requirements while driving process improvements.
Support monitoring initiatives by configuring applicable requirements in MBRs/GMBRs and data monitoring applications (e.g., Enterprise Data Lake, Spotfire).
Ensure configurations align with process design, GMP requirements.
Work closely with process owners, process development, and automation teams to design and implement new processes or modifications.
Use
Application Life Cycle Management (ALM) system
during validations and navigate SAP for master data, process orders, production versions,
inventory, and bill of materials (BOMs).
Qualifications:
Bachelor’s degree in
Engineering
+4 years
of Engineering experience
Experience in biotechnology or pharmaceutical field, downstream process, managing SOPs, eBRs and change controls.
Familiarity with
validation processes.
Familiarity with
documentation in a highly regulated environment.
Ability to operate specialized laboratory equipment and computers as appropriate.
Ability to
interpret and apply GLPs and GMPs.
Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.
Administrative Shift
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status or any other characteristic protected by law.
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Initiate, revise, and approve manufacturing-controlled documents in the document management system.
Serve as document author, owner, reviewer, or data verifier as needed, ensuring all controlled documents accurately reflect current operations and compliance standards.
Implement new product introductions and major projects
within Drug Substance (DS) operations.
Collaborate with Capital and cross-functional teams to define requirements, develop operational strategies, and implement deliverables, including procedures, batch records, automation, materials, new equipment introduction/modifications, cleaning, changeover, process validation, training, and floor readiness.
Analyses floor operations data and observations to identify root causes of deviations or inefficiencies.
Develop and implement data-driven solutions to drive process improvements and enhance operational performance.
Ensure timely investigation and resolution of deviations within established goals.
Perform deviation assessments, support root cause analysis (RCA), human performance evaluations, and CAPA development.
Monitor CAPA effectiveness to prevent recurrence
and take additional corrective actions as needed.
Assist in the development and
execution of process validation protocols and reports.
Collect, analyze, and interpret process validation data to ensure compliance and operational robustness.
Lead or support change control initiatives, ensuring alignment with regulatory and operational requirements while driving process improvements.
Support monitoring initiatives by configuring applicable requirements in MBRs/GMBRs and data monitoring applications (e.g., Enterprise Data Lake, Spotfire).
Ensure configurations align with process design, GMP requirements.
Work closely with process owners, process development, and automation teams to design and implement new processes or modifications.
Use
Application Life Cycle Management (ALM) system
during validations and navigate SAP for master data, process orders, production versions,
inventory, and bill of materials (BOMs).
Qualifications:
Bachelor’s degree in
Engineering
+4 years
of Engineering experience
Experience in biotechnology or pharmaceutical field, downstream process, managing SOPs, eBRs and change controls.
Familiarity with
validation processes.
Familiarity with
documentation in a highly regulated environment.
Ability to operate specialized laboratory equipment and computers as appropriate.
Ability to
interpret and apply GLPs and GMPs.
Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.
Administrative Shift
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status or any other characteristic protected by law.
#J-18808-Ljbffr