Advanced BioScience Laboratories
QA Specialist II - Quality Operations
Advanced BioScience Laboratories, Rockville, Maryland, us, 20849
QA Specialist II - Quality Operations - (00201_COMPANY_1.7)
ABL, Inc. is an Equal Opportunity Employer and is committed to embracing diverse backgrounds. ABL, Inc. does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation or any other characteristic protected by federal, state or local law.
Job Title:
QA Specialist II - Quality OperationsLocation:
[Specify location]Job Type:
Full-timeExemption Type:
ExemptEducation:
Bachelor's DegreeJob Description:The Quality Assurance Specialist II is responsible for supporting QA Operations (Government and/or Commercial) to ensure project objectives are met to a high-quality standard, while ensuring current Good Manufacturing Practices (cGMPs) compliance for manufacturing/testing and compliance with US and EU regulations, as applicable. The position will support QA Operations activities including but not limited to, Lot Disposition, QA on the Floor, QA Client oversight, Client Audits, Data Review, Government Projects, QS Records, Supplier Quality, Training, Document Control, and Management Review. This role will act as a quality resource supporting the GMP organizations across the site.The Specialist II role supports the strategic vision to ensure project objectives are met to a high-quality standard. Exercises judgment within defined Quality Assurance and Manufacturing procedures to determine appropriate action for resolution of manufacturing issues.Ensure current Good Manufacturing Practices (cGMPs) compliance for clinical manufacturing of phase I/II/III investigational biological products, and compliance to 21 CFR Parts 210, 211, and 600 as applicable.Provide Quality Assurance support to concurrent Commercial and/or Government cGMP projects.Conduct Batch Record review as assigned.Support project sub-contractors as assigned.Critically review, approve, and issue various GMP documentation to ensure completeness, accuracy, and compliance; including but not limited to: Manufacturing records, Quality Control Environmental Monitoring data, batch and material release, specifications, SOPs, test methods, GMP analytical and bioanalytical data, product labels, alarm reports, deviation investigations, CAPAs, and change controls.Critically review Quality related documents and procedures from ABL Rockville subcontractors.Support Deviations investigations as assigned.Perform QA On-the-Floor activities supporting client projects, auditing critical processes, reviewing documentation in real-time, and resolving issues that occur during manufacturing.Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements, and industry best practices.Act as first responder for on-the-floor quality issues in a timely manner, documenting all events/investigations and required immediate corrective actions to facilitate right first time (RFTP).Support raw material release.Support AQL inspections.Provide review of QC data as assigned.Provide review of E&F records/data as assigned.Provide QA representation on client project meetings and interact with clients or subcontractor QA personnel, providing feedback on ongoing activities when needed.Review client-provided documents to meet ABL Rockville policies for the entire product lifecycle (release, receipt, manufacturing, and shipment, etc.).Support the generation of quality metrics weekly for ABL with an emphasis on identifying areas for continual improvement and facilitating the implementation of action plans with functional stakeholders.Support the Quality Systems Manager in client, internal, ISO, and regulatory agency inspections.Support risk assessments executed at the site as assigned.Support the creation and delivery of applicable training as assigned.Participate in ABL Rockville audit program including internal, client, and supplier activities.Comply, review, and provide feedback on Quality Systems and associated reports including but not limited to Deviations, CAPAs, Change Control, Quality Risk Assessment, and Management Review in support of ABL Rockville and ABL subcontractor manufacturing operations.Participate in cross-functional teams to address facility issues using methodical problem-solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact to product.Suggest improvements to ABL cGMP activities and Quality System policies and provide expertise and troubleshooting for all Quality related concerns.Identify compliance risks to management with remediation proposals, and lead solution implementation.Work cross-functionally with Project Management, Manufacturing, Facilities, and Quality Control in meeting project deliverables in a compliant and efficient manner.Report quality deficiencies to Supervisor and Department Heads.Interact and plan workload with Supervisor and other Department personnel.Other duties as assigned.Job Requirements:Minimum of a B.S. in a Life Sciences discipline preferred.A Minimum of 4 years of experience within the life sciences industry with at least 2 of those years in a Quality Assurance role.Working knowledge of FDA 21 CFR Part 11/210/211/600, EudraLex, and ISO 9001 quality system standards.Understanding of biological manufacturing processes, cell culture, or viral including cell/virus banking, upstream/downstream Bulk Drug Substance (BDS) production, Final Drug Product.Familiarity with the FDA, MHRA, and EMA Data Integrity Guidelines.Ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.Must be a team player and able to interact with all levels of ABL Rockville and ABL subcontractor staff and Management.Able to be flexible to changing priorities, with the ability to organize and deliver tasks & projects with a sense of urgency under minimal supervision without neglecting attention to detail.Ability to work under pressure, analyze processes within scheduled timeframes, and manage multiple projects simultaneously. Able to work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.Excellent communication skills: oral, written, and listening. Excellent computer skills; strong knowledge of MS Office, Excel, Word, PowerPoint, Outlook, Visio.Persistent.Collaborative minded across all departments.Ability and willingness to learn and help in all areas of QA.Demonstrated understanding and adherence to ABL policies and procedures.Ability to succeed in a team-oriented environment under dynamic conditions.Additional Information:Candidate must meet all the requirements of our Company Occupational Health program as directed by the Occupational Health Consultant to include pre-employment physical and drug screen.Candidates are encouraged to submit a resume and a cover letter outlining background and experience as it relates to the position requirements and salary history/requirements. Please note that “negotiable” is neither salary nor requirements. Salary commensurate with experience.ABL, Inc. participates in E-Verify, an Internet-based system of the Department of Homeland Security (DHS) and Social Security Administration, that allows us to determine an employee's eligibility to work in the United States.
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ABL, Inc. is an Equal Opportunity Employer and is committed to embracing diverse backgrounds. ABL, Inc. does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation or any other characteristic protected by federal, state or local law.
Job Title:
QA Specialist II - Quality OperationsLocation:
[Specify location]Job Type:
Full-timeExemption Type:
ExemptEducation:
Bachelor's DegreeJob Description:The Quality Assurance Specialist II is responsible for supporting QA Operations (Government and/or Commercial) to ensure project objectives are met to a high-quality standard, while ensuring current Good Manufacturing Practices (cGMPs) compliance for manufacturing/testing and compliance with US and EU regulations, as applicable. The position will support QA Operations activities including but not limited to, Lot Disposition, QA on the Floor, QA Client oversight, Client Audits, Data Review, Government Projects, QS Records, Supplier Quality, Training, Document Control, and Management Review. This role will act as a quality resource supporting the GMP organizations across the site.The Specialist II role supports the strategic vision to ensure project objectives are met to a high-quality standard. Exercises judgment within defined Quality Assurance and Manufacturing procedures to determine appropriate action for resolution of manufacturing issues.Ensure current Good Manufacturing Practices (cGMPs) compliance for clinical manufacturing of phase I/II/III investigational biological products, and compliance to 21 CFR Parts 210, 211, and 600 as applicable.Provide Quality Assurance support to concurrent Commercial and/or Government cGMP projects.Conduct Batch Record review as assigned.Support project sub-contractors as assigned.Critically review, approve, and issue various GMP documentation to ensure completeness, accuracy, and compliance; including but not limited to: Manufacturing records, Quality Control Environmental Monitoring data, batch and material release, specifications, SOPs, test methods, GMP analytical and bioanalytical data, product labels, alarm reports, deviation investigations, CAPAs, and change controls.Critically review Quality related documents and procedures from ABL Rockville subcontractors.Support Deviations investigations as assigned.Perform QA On-the-Floor activities supporting client projects, auditing critical processes, reviewing documentation in real-time, and resolving issues that occur during manufacturing.Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements, and industry best practices.Act as first responder for on-the-floor quality issues in a timely manner, documenting all events/investigations and required immediate corrective actions to facilitate right first time (RFTP).Support raw material release.Support AQL inspections.Provide review of QC data as assigned.Provide review of E&F records/data as assigned.Provide QA representation on client project meetings and interact with clients or subcontractor QA personnel, providing feedback on ongoing activities when needed.Review client-provided documents to meet ABL Rockville policies for the entire product lifecycle (release, receipt, manufacturing, and shipment, etc.).Support the generation of quality metrics weekly for ABL with an emphasis on identifying areas for continual improvement and facilitating the implementation of action plans with functional stakeholders.Support the Quality Systems Manager in client, internal, ISO, and regulatory agency inspections.Support risk assessments executed at the site as assigned.Support the creation and delivery of applicable training as assigned.Participate in ABL Rockville audit program including internal, client, and supplier activities.Comply, review, and provide feedback on Quality Systems and associated reports including but not limited to Deviations, CAPAs, Change Control, Quality Risk Assessment, and Management Review in support of ABL Rockville and ABL subcontractor manufacturing operations.Participate in cross-functional teams to address facility issues using methodical problem-solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact to product.Suggest improvements to ABL cGMP activities and Quality System policies and provide expertise and troubleshooting for all Quality related concerns.Identify compliance risks to management with remediation proposals, and lead solution implementation.Work cross-functionally with Project Management, Manufacturing, Facilities, and Quality Control in meeting project deliverables in a compliant and efficient manner.Report quality deficiencies to Supervisor and Department Heads.Interact and plan workload with Supervisor and other Department personnel.Other duties as assigned.Job Requirements:Minimum of a B.S. in a Life Sciences discipline preferred.A Minimum of 4 years of experience within the life sciences industry with at least 2 of those years in a Quality Assurance role.Working knowledge of FDA 21 CFR Part 11/210/211/600, EudraLex, and ISO 9001 quality system standards.Understanding of biological manufacturing processes, cell culture, or viral including cell/virus banking, upstream/downstream Bulk Drug Substance (BDS) production, Final Drug Product.Familiarity with the FDA, MHRA, and EMA Data Integrity Guidelines.Ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.Must be a team player and able to interact with all levels of ABL Rockville and ABL subcontractor staff and Management.Able to be flexible to changing priorities, with the ability to organize and deliver tasks & projects with a sense of urgency under minimal supervision without neglecting attention to detail.Ability to work under pressure, analyze processes within scheduled timeframes, and manage multiple projects simultaneously. Able to work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.Excellent communication skills: oral, written, and listening. Excellent computer skills; strong knowledge of MS Office, Excel, Word, PowerPoint, Outlook, Visio.Persistent.Collaborative minded across all departments.Ability and willingness to learn and help in all areas of QA.Demonstrated understanding and adherence to ABL policies and procedures.Ability to succeed in a team-oriented environment under dynamic conditions.Additional Information:Candidate must meet all the requirements of our Company Occupational Health program as directed by the Occupational Health Consultant to include pre-employment physical and drug screen.Candidates are encouraged to submit a resume and a cover letter outlining background and experience as it relates to the position requirements and salary history/requirements. Please note that “negotiable” is neither salary nor requirements. Salary commensurate with experience.ABL, Inc. participates in E-Verify, an Internet-based system of the Department of Homeland Security (DHS) and Social Security Administration, that allows us to determine an employee's eligibility to work in the United States.
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