ASSOCIATE DIRECTOR, QUALITY ASSURANCE VALIDATION
2 weeks ago
The Associate Director, Quality Assurance Validation plays a critical role in ensuring the integrity, compliance, and reliability of equipment, methods, processes, and computerized systems within the GMP environment. This position provides support and quality assurance guidance to the Technical Operation's department ensuring that the lifecycle of the validation program follows all regulatory requirements. In this role, you will use your knowledge to ensure site validation activities align with Kriya's Validation Policy, Site Validation Master Plan, and applicable Quality Systems.
How You Contribute
* Collaborate with cross-functional teams to develop and execute a robust validation strategy for equipment, utilities, and computer software assurance (CSA), that align with regulatory requirements.
* Work with various departments to define the validation scope, deliverables, and timelines.
* Review and approve validation documents including SOPs, protocols, specifications, test scripts, acceptance criteria, and reports.
* Ensure implementation, operation, and validation of GXP computerized systems follow GAMP 5 guidelines.
* Participate in risk assessments related to GXP equipment, utilities, and computerized systems.
* Identify and address potential risks to data integrity, security, and safety.
* Provide quality support for change control processes and activities that occur for any modifications to existing or new systems, equipment, instruments, or utilities to ensure validation requirements are assessed and fulfilled.
* Review validation exception records and investigations.
* Lead and participate in CSV vendor audits.
* Support biennial reviews of validated systems as required.
* Provide various quality support in other areas of Quality that include batch record review, data review, material release, vendor and regulatory audits, SOP review, and other document reviews, as needed.
What You Bring to the Team
Education & Experience
* Minimum - Bachelor's or Masters's degree preferably in an Engineering, Science, Technical, or related fields.
* Relevant certifications such as CQA are preferred.
* 10+ years of experience in Quality Assurance and Validation within the biotechnology workforce.
Competencies
* Thorough knowledge of applicable regulations and standards related to validation activities.
* Experience working in a cGMP environment.
* Detailed knowledge of GAMP 5 applications and CSA approach.
* Proficiency in Microsoft Suite
* Ability to manage daily work activities of this role with minimal supervision.
* Strong orientation for quality and cGMPs
* Strong collaborative skills.
* Highly self-motivated and detail oriented.
* Demonstrated level of respect for individuals
* High level of integrity and personal responsibility
Working Conditions and Physical Demands
* Work is normally performed: at a desk
* Lifting requirements: Under 20 lbs
* Travel requirements: Occasional
About Kriya
Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.
We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.
What We Offer
Medical, Dental and Vision with 100% employee premium coverage ∙ Retirement matching ∙ Short and long-term disability benefits ∙ 12 company paid holidays ∙ Generous Time Off ∙ Cyber Safety protection ∙ EAP ∙ Company paid life insurance ∙ Equity ∙ and more
Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
All job requirements in the job description provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.
-
Associate Director, Quality Assurance Validation
2 weeks ago
Morrisville, United States Kriya Therapeutics Full timeWho You Are The Associate Director, Quality Assurance Validation plays a critical role in ensuring the integrity, compliance, and reliability of equipment, methods, processes, and computerized systems within the GMP environment. This position provides support and quality assurance guidance to the Technical Operation's department ensuring that the lifecycle...
-
Quality Assurance Associate
4 days ago
New Hanover County, NC, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of QA Associate – Report Generation. The candidate will be responsible for review and approval of reports generated from laboratory data, such as certificate of analysis and stability study...
-
New Hanover County, NC, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of QA Associate - Report Generation. The candidate will be responsible for review and approval of reports generated from laboratory data, such as certificate of analysis and stability study tables...
-
Assurance Associate Director
1 day ago
Raleigh, NC, United States VACO Full timeAssurance Associate DirectorVaco has exclusively partnered with Dean Dorton to fuel their market growth and build out their Raleigh team. Dean Dorton offers a hybrid work schedule at their conveniently located office, business development opportunities and incentives, advancement opportunities, unlimited PTO, and great work/life balance.As the Assurance...
-
Software Quality Assurance Engineer
6 days ago
Morrisville, United States Ad Astra Diagnostics Full timeJob DescriptionJob DescriptionAd Astra Diagnostics, Inc. (AAD) is looking for an experienced Software Quality Assurance Engineer to assist the company in developing a class-leading Point-of-Care diagnostic platform for the human market in a small anddynamic team.You will be leading the efforts of testing a Medical Device Software, including data...
-
Software Quality Assurance Engineer
1 day ago
Morrisville, United States Ad Astra Diagnostics Full timeJob DescriptionJob DescriptionAd Astra Diagnostics, Inc. (AAD) is looking for an experienced Software Quality Assurance Engineer to assist the company in developing a class-leading Point-of-Care diagnostic platform for the human market in a small and dynamic team.You will be leading the efforts of testing a Medical Device Software, including data...
-
Quality Associate II
2 weeks ago
Morrisville, United States Innova Solutions Full timeInnova Solutions is immediately hiring for a Quality Associate II Position : Type: Full Time, ContractDuration :13+ MonthsLocation: Morrisville North Carolina 27560Job Description:The Quality Associate II (Contractor) is responsible for contributing to the oversight of key strategic, and operational aspects within Quality Assurance at the Client Research...
-
Morrisville, United States SynergenX Full timeJob DescriptionJob DescriptionTomorrowMed Pharma is a pioneering 503B manufacturing facility poised to revolutionize the pharmaceutical compounding industry. Situated in the heart of Research Triangle Park in Raleigh, NC, this brand-new cutting-edge cGMP facility adheres to strict regulatory standards set by the FDA to ensure the safety, efficacy, and...
-
Associate Scientist, Sterility Assurance
2 weeks ago
Morrisville, United States Teleflex, Inc. Full timeSupport sterilization/microbiological methods and process controls related to purchased products designed by Teleflex Medical and manufactured by contractors, products designed and manufactured by Teleflex Medical and/or purchased products labeled an Scientist, Associate, Assurance, Monitoring, Support, Medical, Business Services
-
QUALITY ASSURANCE NURSE
1 week ago
San Francisco, CA 94111, USA, United States Self-Help for the Elderly Full timeTitle:Quality Assurance NurseDepartment: Home Care & HospiceFLSA Status: Non-ExemptReports To: Director of Patient Care Services/AdministratorSummary: The Quality Assurance Nurse is responsible for evaluating clinical practices within Self-Help Home Care & Hospice and implementing changes for improvement. The Quality Assurance Nurse shall possess Home Health...
-
RN, QUALITY ASSURANCE, HOME CARE
1 week ago
Roseville, CA 95661, USA, United States Adventist Health NW Full timeOur home health and hospice agencies are located throughout California, Hawaii, Oregon and Washington. They serve the entire community and offer personalized in-home care, and many have been recipients of Home Care Elite awards.So whether you're looking for the buzz of a large city, the tranquility of nearby mountain bike trails or something in between, we...
-
RN, QUALITY ASSURANCE, HOME CARE
1 week ago
Roseville, CA 95661, USA, United States Adventist Health Full timeJob DescriptionOur home health and hospice agencies are located throughout California, Hawaii, Oregon and Washington. They serve the entire community and offer personalized in-home care, and many have been recipients of Home Care Elite awards.So whether you're looking for the buzz of a large city, the tranquility of nearby mountain bike trails or something...
-
Validation Engineer
2 weeks ago
New Hanover County, NC, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Validation Engineer. This position, in the Manufacturing and Formulations Services department, requires a Bachelor’s degree or higher in a scientific or engineering discipline with either 3...
-
New Hanover County, NC, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a pharmaceutical testing and development lab in Wilmington, is seeking highly motivated candidates for qualified analytical data reviewers, LabWare LIMS development/configuration/validation, Document Control Associates, Computer System Validation and Data Integrity Specialists, Scientists (all levels) with experience in...
-
QUALITY ASSURANCE NURSE
1 week ago
Tulsa, OK 74128, USA, United States Brookhaven Hospital Full timeBrookhaven Hospital - Signing Bonus available! Pay commensurate with experience or education.Brookhaven Hospital is pleased to announce an opening for a Quality Assurance Nurse. The Quality Assurance Nurse is responsible for promoting quality and cost effective outcomes for Brookhaven Hospital’s continuum of care by applying the policies and procedures...
-
Quality Assurance Engineer
6 days ago
Durham, NC, United States Digital Turbine Full timeAbout the Quality Assurance Engineer:You will be a part of a dedicated and talented team of QA Engineers and Developers that ship high scale and high availability services, SDK's, and features that impact millions of people each day.Use and grow your test skills by owning features end-to-end, developing accurate test metrics to determine coverage and test...
-
Design & Construction Project Manager
1 week ago
Morrisville, NC, 27560, Wake County, NC, United States First Citizens Bank Full timeOverview: This position manages building construction and renovation projects for Corporate Real Estate (CRE). Identifies project partner resources, assists in the development of design/bid documents and contractor negotiations. Coordinates project activities and work teams, facilitating clear communication and project workflow to successfully achieve...
-
Roseville, CA 95661, USA, United States Adventist Health Full timeJob DescriptionOur home health and hospice agencies are located throughout California, Hawaii, Oregon and Washington. They serve the entire community and offer personalized in-home care, and many have been recipients of Home Care Elite awards.So whether you're looking for the buzz of a large city, the tranquility of nearby mountain bike trails or something...
-
REGISTERED NURSE, HEALTH CENTER MANAGER
1 week ago
Morrisville, NC 27560, USA, United States Premise Health Systems Full timeHealthcare Without RivalPremise Health is the world's leading direct healthcare provider and one of the largest digital providers in the country, serving over 11 million eligible lives across more than 2,500 of the largest commercial and municipal employers in the U.S. Premise partners with its clients to offer fully connected care - in-person and in the...
-
QUALITY ASSURANCE/ POINT OF CARE COORDINATOR
7 days ago
White Plains, NY 10601, USA, United States White Plains Hospital Center Full timeWhite Plains Hospital Job Description Title:Point of Care CoordinatorJob Code:500299 Department/Location:Department of Laboratories FLSA Status: NE Reports to:Laboratory Supervisor Position SummaryUnder guidance of the Laboratory Supervisor and Medical Director, applies practical and theoretical knowledge of point of care technology as it applies to point of...