BioSpace, Inc.
Senior Associate II, Quality Operations
BioSpace, Inc., Durham, North Carolina, United States, 27703
Job Details
A career at Resilience is more than just a job - it's an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit www.resilience.com
Position Summary
The Senior Associate II, Quality Operations, provides the quality activities supporting Manufacturing and other functions such as QC and Facilities in accordance with Resilience policies, standards, procedures, and cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing real-time review of manufacturing records and logbooks, and working with Manufacturing Operations to resolve issues. This role reports to the Sr. Manager of Quality Operations located at the RTP site and requires work to be performed onsite. In this position, approximately 15% of the job responsibilities will require a presence in manufacturing production areas to support active batch processing and perform real-time review of documentation.
Job ResponsibilitiesReview and approve records in the Quality Management System as QA Approver for Change Controls, Deviations, CAPAs, and Risk Assessments.Review and approve operational SOPs, Master Batch Records, raw material specifications, protocols, reports, and logbook templates.Review manufacturing batch production records and supporting documentation (logbooks, alarm reports, work orders, disruptions to a controlled environment, etc.).Actively monitor manufacturing activities within the production suites to support potential quality/compliance events, provide guidance on documentation comments, and ensure compliance with applicable procedures.Perform area and process walkthroughs within manufacturing, warehouse, and utility areas.Approve inventory management system Master Data including Bill of Materials for production.Build and maintain relationships with Manufacturing Operations, Manufacturing Science & Technology, and other departments to effectively accomplish responsibilities, make improvements, and resolve issues.Ensure compliance with applicable procedures and production requirements. Perform follow-up on potential non-compliances and escalate to management as necessary.Client interactions - Event and Change Control Notification to Clients, joint working sessions on investigations and technology transfers, and other client-facing responsibilities.Support phase-appropriate technology transfersCross-training - Supports QA oversight for Quality Control (QC) through review and approval of raw material specifications, stability protocols and reports, CoAs and Analytical Summary Forms, environmental monitoring investigations, QC-related minor deviations, and compendial method verifications.For all activities described above:
Critically review each task, ask questions, interpret information and results, and generate conclusions consistent with Quality risk management principles.Provide direct feedback to individuals performing work and Supervisors regarding observations made during review and steps required to remediate such as comments to correct documentation and decision whether a deviation is requiredWork Schedule:
Monday-Friday during normal day shift working hours requiring occasional on-call and on-site support for off-shift manufacturing activities.Minimum Qualifications
Quality and Compliance mindsetDemonstrated ability to successfully execute responsibilities in a fast-paced environment, manage multiple responsibilities, and collaborate cross-functionallySubstantial hands-on experience using electronic Quality Management System (eQMS) and performing work such as Change Control, Deviation, and CAPA.Strong knowledge of cGMP manufacturing processes for biologics, vaccines, cell or gene therapy productsStrong authorship/technical writing and ability to critically review deviation investigations, interpret results, and generate technical conclusions consistent with Quality risk management principles.Skilled in planning and organizing tasks, decision-making, and communicating expectations and feedback associated with Quality reviews.Preferred Qualifications
Bachelor's degree or higher in Life Sciences discipline. 10+ years of experience in a GMP-regulated environment involving responsibilities in a Quality function may be substituted in lieu of a degree.Minimum of 6 years of pharmaceutical or biopharmaceutical industry experience, with a minimum of 2 years of experience working with Quality Systems (deviation, CAPA, change control) or in Quality Assurance.Continuous improvement mindsetExperience with delivering presentations, facilitating, and teaching to diverse audiencesDesire and interest to leverage new technology and innovative learning techniquesExcellent interpersonal, verbal, and written communication skillsExperience supporting regulatory inspectionsData and metric-drivenFormal training and experience as a trainer in root cause analysis, problem-solving techniques, and technical writingKnowledge of phase-appropriate quality systems and product lifecycle requirementsStrong attention to detail.
The items described here are representative of those that must be met successfully to perform the essential functions of this job.
Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.
Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $100,000.00 - $137,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.
A career at Resilience is more than just a job - it's an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit www.resilience.com
Position Summary
The Senior Associate II, Quality Operations, provides the quality activities supporting Manufacturing and other functions such as QC and Facilities in accordance with Resilience policies, standards, procedures, and cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing real-time review of manufacturing records and logbooks, and working with Manufacturing Operations to resolve issues. This role reports to the Sr. Manager of Quality Operations located at the RTP site and requires work to be performed onsite. In this position, approximately 15% of the job responsibilities will require a presence in manufacturing production areas to support active batch processing and perform real-time review of documentation.
Job ResponsibilitiesReview and approve records in the Quality Management System as QA Approver for Change Controls, Deviations, CAPAs, and Risk Assessments.Review and approve operational SOPs, Master Batch Records, raw material specifications, protocols, reports, and logbook templates.Review manufacturing batch production records and supporting documentation (logbooks, alarm reports, work orders, disruptions to a controlled environment, etc.).Actively monitor manufacturing activities within the production suites to support potential quality/compliance events, provide guidance on documentation comments, and ensure compliance with applicable procedures.Perform area and process walkthroughs within manufacturing, warehouse, and utility areas.Approve inventory management system Master Data including Bill of Materials for production.Build and maintain relationships with Manufacturing Operations, Manufacturing Science & Technology, and other departments to effectively accomplish responsibilities, make improvements, and resolve issues.Ensure compliance with applicable procedures and production requirements. Perform follow-up on potential non-compliances and escalate to management as necessary.Client interactions - Event and Change Control Notification to Clients, joint working sessions on investigations and technology transfers, and other client-facing responsibilities.Support phase-appropriate technology transfersCross-training - Supports QA oversight for Quality Control (QC) through review and approval of raw material specifications, stability protocols and reports, CoAs and Analytical Summary Forms, environmental monitoring investigations, QC-related minor deviations, and compendial method verifications.For all activities described above:
Critically review each task, ask questions, interpret information and results, and generate conclusions consistent with Quality risk management principles.Provide direct feedback to individuals performing work and Supervisors regarding observations made during review and steps required to remediate such as comments to correct documentation and decision whether a deviation is requiredWork Schedule:
Monday-Friday during normal day shift working hours requiring occasional on-call and on-site support for off-shift manufacturing activities.Minimum Qualifications
Quality and Compliance mindsetDemonstrated ability to successfully execute responsibilities in a fast-paced environment, manage multiple responsibilities, and collaborate cross-functionallySubstantial hands-on experience using electronic Quality Management System (eQMS) and performing work such as Change Control, Deviation, and CAPA.Strong knowledge of cGMP manufacturing processes for biologics, vaccines, cell or gene therapy productsStrong authorship/technical writing and ability to critically review deviation investigations, interpret results, and generate technical conclusions consistent with Quality risk management principles.Skilled in planning and organizing tasks, decision-making, and communicating expectations and feedback associated with Quality reviews.Preferred Qualifications
Bachelor's degree or higher in Life Sciences discipline. 10+ years of experience in a GMP-regulated environment involving responsibilities in a Quality function may be substituted in lieu of a degree.Minimum of 6 years of pharmaceutical or biopharmaceutical industry experience, with a minimum of 2 years of experience working with Quality Systems (deviation, CAPA, change control) or in Quality Assurance.Continuous improvement mindsetExperience with delivering presentations, facilitating, and teaching to diverse audiencesDesire and interest to leverage new technology and innovative learning techniquesExcellent interpersonal, verbal, and written communication skillsExperience supporting regulatory inspectionsData and metric-drivenFormal training and experience as a trainer in root cause analysis, problem-solving techniques, and technical writingKnowledge of phase-appropriate quality systems and product lifecycle requirementsStrong attention to detail.
The items described here are representative of those that must be met successfully to perform the essential functions of this job.
Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.
Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $100,000.00 - $137,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.