Lead Specialist, QA Validation
Company: Resilience
Location: Durham
Posted on: January 25, 2023
Job Description:
Resilience (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 .Position
Summary & RoleThe Lead Specialist, QA Validation is a member of
Resilience RTP enthusiastic and collaborative Quality Assurance
Validation (QAV) team and contributes to the overall success of our
novel gene therapy. The focus of this position is to support the
organization through the establishment of Resilience
validation/qualification programs across disciplines and ensure
alignment with regulatory requirements and industry standards in
accordance with the relevant product's lifecycle. This position is
responsible for guidance and technical review of protocols and
reports related to equipment, facilities, computer systems,
technology transfers, test methods, cleaning, process validation,
cold chain storage and shipping validation activities. These
activities will encompass technology transfer and commercial
projects. The Lead Specialist, QA Validation will own, lead or
support multidisciplinary, multi-site, moderate to complex
projects.Job Responsibilities:
- Provide QA support, input and oversight for the manufacturing
site
- Provide QA support for validation activities including:
- Process Validation
- Analytical instrument qualification, use and maintenance
- Computer systems validation
- Equipment Utilities, and Facilities commissioning,
qualification, use and maintenance
- Validation of Cleaning, Sterilization, and Decontamination
processes
- Provide guidance, review and approval of internal validation
documents including validation plans, requirement documents (URS,
FS, CS), protocols, data analysis, and final reports.
- Ability to drive the implementation of new policies and
procedures to support Resilience quality systems.
- Ability to exercise judgment within and outside of defined
procedures and practices to determine appropriate action.
- Ability to multitask, manage timelines and prioritize
independently in a high paced environment.
- Thorough knowledge and understanding of FDA and foreign
requirements and expectations.
- Works closely with all site functional teams (Manufacturing,
Facilities, QC, etc) responsible for protocol development and
execution to provide QAV support.
- Provide support of Resilience internal QC lab along with
assay/method development.
- QA Approval of change controls and validation documents e.g.
Impact Assessment, Risk Assessment, Protocol, Report, and User
Requirements.
- Represent the Quality Assurance Validation group in project
teams, audits and inspections as required.
- Support the development of solutions to problems of varying
complexity which require a high degree of ingenuity, creativity,
and innovativeness.
- Support the development of long-range goals and
objectives.
- Exercise considerable latitude in determining objectives and
approaches to critical assignments.Preferred Experience, Education
& Qualifications:
- Wide range of expertise or working knowledge across validation
disciplines outlined above.
- Expertise in support of Tech Transfer initiatives.
- Experience with upstream, downstream or fill/finish
manufacturing.
- Bachelors' and/or Masters' degree in Engineering, Biochemistry
or related field required. Technical understanding of
biopharmaceutical production.
- A minimum often (10) years of experience in the industry,
ideally all clinical phases through commercial drug product.
- Knowledge of cGMP guidelines, ICH Q7, Q8, Q9, QlO and other
international regulatory requirements relevant for process,
cleaning and equipment validation.
- Knowledgeable of Data Integrity requirements.
- Leadership skills to lead cross functional teams to ensure
project success.
- Excellent written and verbal communication skills including the
ability to communicate, influence and negotiate across the
organization.
- Microsoft Office, including Word, Excel, PowerPoint, Outlook,
MS Project.
- Ability to travel approximately 5-10% based on project
demand.
- Experience within a multi-product facility is a plus.
- Experience using risk-based approaches (FMEA, PHA, etc).
- Project management experience.
- Strong analytical ability.
- Experience supporting internal regulatory and partner
inspections.
- Demonstrates initiative; ability to undertake additional
responsibilities and respond to situation as they arise with little
or no supervision.
- Ability to make independent sound decisions and independently
manage priorities in alignment with department and site
drivers.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 $115,000.00 - $145,000.00. 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.
Keywords: Resilience, Durham , Lead Specialist, QA Validation, Other , Durham, North Carolina
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