Senior Specialist, Quality Compliance QAOTF
General Company DescriptionRESILIENCE (National Resilience, Inc.
) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.
Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale.
RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes.
By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients' lives.
For more information, visit www.
resilience.
com.
SummaryThe Senior Specialist, QAOTF (Quality Assurance on The Floor) Quality Operations is an individual contributor role responsible for direct interface with clients having the ability to manage all quality-related issues.
The authoring of deviations classified as Event / Deviations, Minor, Major, and Critical deviations, and associated investigations.
Performing and assessing the 24-hour triage of incidents in manufacturing and assessing the path forward.
Review and approval of production batch records requiring client approvals and collaborations.
Responsibilities may also include but are not limited to management and tracking of deviation and CAPA and Change Control records, support of the day-to-day Quality Operations daily activities, and batch disposition.
Overall project oversight with active real-time oversight of all activities on the manufacturing floor during project campaigns.
Responsibilities Quality review of manufacturing process and batch records real time in the manufacturing area.
Ensuring compliance with GDP and GMP practices during aseptic processing activities.
Collaborate with the manufacturing teams as needed to reconcile errors on a timely basis.
Lead the 24-hour triage of incidents and open initial records in the QMS system.
(Deviations and Change controls, etc.
) Work on the manufacturing floor for data gathering, observing of processes for investigations, and performance of associate interview.
Communicate findings to Quality Operations team during tier meetings.
Escalate major and critical observations to management.
Ability to work alone as the single point of contact for client interface meetings representing all Quality activities providing direct support to client ensuring projects are successful and meets client expectations.
Complete deviations, CAPAs, change controls, document revisions and training activities to meet quality system requirements and timelines.
Ensuring the written record contains the technical merit and completeness according to regulatory expectations.
Gathering Data from various sources across the site, support Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation, Assessment of event for impact, Identification of Corrective and Preventative Actions to reduce deviation recurrence, performance and leading of Risk Assessments, Causing Mapping, Interviewing.
Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
Support the batch disposition process to ensure timely deliverables to the client.
Participation in the Daily Tier meetings to update leadership on current deviation statuses.
Must be able to work independently and as a team.
Ability to adapt to changing priorities and manage multiple assignments while meeting timeline.
Strong written and verbal communication skills are required.
Ability to read and comprehend complex subjects.
Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems.
Expertise in GMP compliance and FDA regulations.
Demonstrated excellence in technical writing and oral communication skills.
Ability to communicate effectively to key stakeholders.
Ability to work cross-functionally and to develop and maintain strong business partner relationships.
Innovative, proactive, and resourceful; committed to quality and continuous improvement.
Ability to anticipate and mitigate challenges between teams.
Perform Gemba's and report findings and develop corrective actions.
Support PIP (Person in Plant) activities from clients and assist with debrief meetings with client.
Minimum Qualifications Extensive experience in a regulated industry (vaccine, biologics, pharmaceutical) Comprehensive understanding of the quality function or GMP experience within a manufacturing organizationPreferred
Qualifications:
Bachelor of Science in relevant studies with relevant experience Experience and knowledge of cGMPs and applicable FDA/EMA regulations in the biotechnology/pharmaceutical industry.
Experience with Master Control, QAD, and LIMS.
Experience with using Quality Risk Management principles.
Experience as a single point of contact for CDMO clients and vendors.
Physical RequirementsSedentary work.
Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body.
Sedentary work involves sitting most of the time.
Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
Light work.
Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.
Medium work.
Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects.
This job requires the employee to perform the following physical activities:
ClimbingBalancingFingeringStoopingKneelingRepetitive motionCrouchingCrawlingFeelingReachingStandingGraspingWalkingPushingHearingPullingLiftingTalkingThis job requires the employee to perform the following type of physical work:
Temperature changesActivities occur inside and outsideThis job requires the following visual activity requirements:
preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.
determines the accuracy, neatness, and thoroughness of the work assigned (i.
e.
, custodial, food services, general laborer, etc.
) or to make general observations of facilities or structures (i.
e.
, security guard, inspection, etc.
).
This job requires exposure to the following:
Noise (enough noise to cause the employee to shout to be heard above ambient noise level.
)Hazards:
moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).
Hazards:
packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.
Narrow aisles or passageways.
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 annualized base pay hiring range for this position is $85,000.
00 - $107,500.
00.
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.
Recommended Skills Adaptability Biopharmaceuticals Biotechnology Business Process Improvement Certified Global Meeting Planner Communication Estimated Salary: $20 to $28 per hour based on qualifications.
) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption.
Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale.
RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes.
By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients' lives.
For more information, visit www.
resilience.
com.
SummaryThe Senior Specialist, QAOTF (Quality Assurance on The Floor) Quality Operations is an individual contributor role responsible for direct interface with clients having the ability to manage all quality-related issues.
The authoring of deviations classified as Event / Deviations, Minor, Major, and Critical deviations, and associated investigations.
Performing and assessing the 24-hour triage of incidents in manufacturing and assessing the path forward.
Review and approval of production batch records requiring client approvals and collaborations.
Responsibilities may also include but are not limited to management and tracking of deviation and CAPA and Change Control records, support of the day-to-day Quality Operations daily activities, and batch disposition.
Overall project oversight with active real-time oversight of all activities on the manufacturing floor during project campaigns.
Responsibilities Quality review of manufacturing process and batch records real time in the manufacturing area.
Ensuring compliance with GDP and GMP practices during aseptic processing activities.
Collaborate with the manufacturing teams as needed to reconcile errors on a timely basis.
Lead the 24-hour triage of incidents and open initial records in the QMS system.
(Deviations and Change controls, etc.
) Work on the manufacturing floor for data gathering, observing of processes for investigations, and performance of associate interview.
Communicate findings to Quality Operations team during tier meetings.
Escalate major and critical observations to management.
Ability to work alone as the single point of contact for client interface meetings representing all Quality activities providing direct support to client ensuring projects are successful and meets client expectations.
Complete deviations, CAPAs, change controls, document revisions and training activities to meet quality system requirements and timelines.
Ensuring the written record contains the technical merit and completeness according to regulatory expectations.
Gathering Data from various sources across the site, support Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation, Assessment of event for impact, Identification of Corrective and Preventative Actions to reduce deviation recurrence, performance and leading of Risk Assessments, Causing Mapping, Interviewing.
Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
Support the batch disposition process to ensure timely deliverables to the client.
Participation in the Daily Tier meetings to update leadership on current deviation statuses.
Must be able to work independently and as a team.
Ability to adapt to changing priorities and manage multiple assignments while meeting timeline.
Strong written and verbal communication skills are required.
Ability to read and comprehend complex subjects.
Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems.
Expertise in GMP compliance and FDA regulations.
Demonstrated excellence in technical writing and oral communication skills.
Ability to communicate effectively to key stakeholders.
Ability to work cross-functionally and to develop and maintain strong business partner relationships.
Innovative, proactive, and resourceful; committed to quality and continuous improvement.
Ability to anticipate and mitigate challenges between teams.
Perform Gemba's and report findings and develop corrective actions.
Support PIP (Person in Plant) activities from clients and assist with debrief meetings with client.
Minimum Qualifications Extensive experience in a regulated industry (vaccine, biologics, pharmaceutical) Comprehensive understanding of the quality function or GMP experience within a manufacturing organizationPreferred
Qualifications:
Bachelor of Science in relevant studies with relevant experience Experience and knowledge of cGMPs and applicable FDA/EMA regulations in the biotechnology/pharmaceutical industry.
Experience with Master Control, QAD, and LIMS.
Experience with using Quality Risk Management principles.
Experience as a single point of contact for CDMO clients and vendors.
Physical RequirementsSedentary work.
Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body.
Sedentary work involves sitting most of the time.
Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
Light work.
Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.
Medium work.
Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects.
This job requires the employee to perform the following physical activities:
ClimbingBalancingFingeringStoopingKneelingRepetitive motionCrouchingCrawlingFeelingReachingStandingGraspingWalkingPushingHearingPullingLiftingTalkingThis job requires the employee to perform the following type of physical work:
Temperature changesActivities occur inside and outsideThis job requires the following visual activity requirements:
preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.
determines the accuracy, neatness, and thoroughness of the work assigned (i.
e.
, custodial, food services, general laborer, etc.
) or to make general observations of facilities or structures (i.
e.
, security guard, inspection, etc.
).
This job requires exposure to the following:
Noise (enough noise to cause the employee to shout to be heard above ambient noise level.
)Hazards:
moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals).
Hazards:
packaging, shipping, handling, or decontamination of blood or other potentially infectious materials (OPIM), including continuous human cell lines.
Narrow aisles or passageways.
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 annualized base pay hiring range for this position is $85,000.
00 - $107,500.
00.
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.
Recommended Skills Adaptability Biopharmaceuticals Biotechnology Business Process Improvement Certified Global Meeting Planner Communication Estimated Salary: $20 to $28 per hour based on qualifications.
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