Current jobs related to Associate Director, Quality Assurance - Spring - Cellipont Bioservices

  • Associate Director, Quality Assurance Lead

    3 days ago

    Spring Hills, Texas, United States Cellipont Bioservices Full time

    Job OverviewCellipont Bioservices is seeking an experienced Associate Director, Quality Assurance to lead our quality assurance team and ensure the highest standards of quality and compliance in our manufacturing processes.Key ResponsibilitiesProvide strategic oversight and leadership to QA Client liaisons and operations to ensure project objectives are met...

  • Director of Quality Assurance and Compliance

    2 weeks ago

    Silver Spring, Maryland, United States eSimplicity Inc Full time

    About eSimplicity InceSimplicity Inc is a modern digital services company that partners with government clients to improve the health and lives of millions of Americans, ensure the security of all Americans, and defend national interests.Job SummaryWe are seeking an experienced Director of Quality Control and Assurance to lead our quality management...

  • Director of Quality Assurance and Compliance

    1 month ago

    Silver Spring, Maryland, United States eSimplicity Full time

    Job Title: Director of Quality Control and AssuranceAbout eSimplicityeSimplicity is a modern digital services company that partners with government clients to improve the health and lives of millions of Americans. We work across government to ensure the security of all Americans and defend national interests on the battlefield.Job SummaryWe are seeking an...

  • RN Quality Assurance Coordinator

    4 days ago

    Sandy Spring, United States Brooke Grove Retirement Village Full time

    Job Title: RN Quality Assurance CoordinatorBrooke Grove Retirement Village is seeking a highly skilled RN Quality Assurance Coordinator to join our team. As a key member of our quality assurance team, you will be responsible for planning, organizing, and directing the quality assurance program and education and training programs for all staff members.Key...

  • Quality Assurance Specialist

    1 week ago

    Silver Spring, Maryland, United States Alaka`ina Foundation Family of Companies Full time

    We are seeking a Quality Assurance Officer to support our government customer on site in Silver Spring, Maryland.The successful candidate will be responsible for ensuring the quality and integrity of all onsite Clinical Trial activities, including conducting audits and reviews/analyses of data and documentation.Key responsibilities include:Developing,...

  • Quality Assurance Specialist

    2 weeks ago

    Silver Spring, Maryland, United States Alaka`ina Foundation Family of Companies Full time

    Job Title: Quality Assurance OfficerAlaka`ina Foundation Family of Companies is seeking a highly skilled Quality Assurance Officer to support our government customer on site in Silver Spring, Maryland.Key Responsibilities:Ensure Quality Assurance/Regulatory Compliance of all onsite Clinical Trial activitiesConduct audits and reviews/analyzes data and...

  • Nurse Quality Assurance Specialist

    2 weeks ago

    Silver Spring, Maryland, United States Incredible Health Full time

    Incredible Health is actively hiring for a Registered Nurse - Quality Assurance Coordinator position in the Silver Spring, MD area. The ideal candidate will have experience in areas such as Assistant Nurse Manager, Audit, CNO, Charge, Clinical Nurse Coordinator, Director, Manager, Patient Safety, Performance Improvement, Supervisor, or VP. Responsibilities...

  • Quality Assurance Specialist

    2 weeks ago

    Silver Spring, Maryland, United States Alaka`ina Foundation Family of Companies Full time

    Join our team as a Quality Assurance Specialist and support our government customer on site in Silver Spring, Maryland.Responsibilities: Ensure Quality Assurance/Regulatory Compliance of all onsite Clinical Trial activities Conduct audits and reviews/analyzes data and documentation Develops, maintains, and ensures compliance with Standard Operating...

  • Quality Assurance Specialist

    1 month ago

    Spring, Texas, United States TPI Staffing, Inc Full time

    Job Title: Quality Assurance TechnicianJob Summary:We are seeking a highly skilled Quality Assurance Technician to join our team at TPI Staffing, Inc. in Spring, Texas. As a Quality Assurance Technician, you will play a crucial role in ensuring that our products meet the highest quality standards and specifications.Key Responsibilities:Conduct regular...

  • Quality Assurance Lead Operations

    1 month ago

    Spring, Texas, United States Cellipont Bioservices Full time

    Job OverviewCellipont Bioservices is seeking a highly skilled Quality Assurance Lead, Operations to join our team. As a key member of our quality team, you will be responsible for leading client project teams, managing relationships, and driving project deliverables.The ideal candidate will have a strong background in quality assurance, with experience in...

  • Quality Assurance Specialist

    4 weeks ago

    Spring Grove, Illinois, United States SCOT FORGE Full time

    Job Title: Quality Assurance SpecialistScot Forge Company is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring that our products meet the highest standards of quality and compliance.Key Responsibilities:Review and interpret specifications to ensure compliance...

  • Associate Director of Creative Services

    2 weeks ago

    Silver Spring, Maryland, United States Children's National Full time

    Job Title: Associate Director of Creative ServicesThe Associate Director of Creative Services will play a key role in the production of print, digital, and web assets for all marketing needs, including proposals, campaigns, presentations, and stewardship reports. This position will work closely with the Creative Director to develop and implement creative...

  • Quality Assurance Specialist

    4 weeks ago

    Spring, Texas, United States W Industries Full time

    Job Title: Quality Control InspectorW-Industries is a leading provider of automation solutions, I&E construction services, power generation, and packaged equipment for the energy and industrial markets. Our expertise spans the full spectrum of system technologies, from pneumatic and hydraulic control systems to state-of-the-art programmable solutions and...

  • Quality Assurance Manager

    1 week ago

    Spring Hill, Tennessee, United States Universal Logistics Holdings Full time

    Job Title: Quality Assurance ManagerUniversal Logistics Holdings is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and safety in our operations.Key Responsibilities:Develop and implement quality management systems to minimize risks...

  • Service Quality Assurance Specialist

    3 weeks ago

    Silver Spring, Maryland, United States Stratton Amenities Full time

    Job Title: Service Quality Assurance SpecialistAt Stratton Amenities, we are seeking a highly skilled Service Quality Assurance Specialist to join our team. As a Service Quality Assurance Specialist, you will be responsible for assessing hospitality and service engagement as it relates to the resident, guest, and client experience.Key...

  • Supplier Quality Assurance Specialist

    2 weeks ago

    Spring, Texas, United States TPI Staffing Group Full time

    Job Title: Supplier Quality Assurance SpecialistAt TPI Staffing Group, we are seeking a highly skilled Supplier Quality Assurance Specialist to join our team. This is a crucial role in ensuring that products distributed by industrial vendors and manufactured by our company meet all required quality standards and specifications.Job Summary:This role involves...

  • Quality Assurance Specialist

    2 weeks ago

    Spring Grove, Illinois, United States Scot Forge Full time

    Quality Assurance SpecialistScot Forge Company is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring that our products meet the highest standards of quality and compliance.This role will involve working closely with our sales, process engineering, manufacturing...

  • Quality Assurance Manager

    1 week ago

    Silver Spring, Maryland, United States TestPros Full time

    Job Title: Quality Assurance ManagerTestPros is seeking an experienced Quality Assurance Manager to lead our QA efforts in responding to an FDA project. The ideal candidate will have a strong background in regulatory compliance, particularly with FDA regulations, and will ensure that all deliverables meet the highest quality standards.Key...

  • Quality Assurance Manager

    7 days ago

    Silver Spring, Maryland, United States TestPros Full time

    Job Title: Quality Assurance ManagerJob Summary:We are seeking an experienced Quality Assurance Manager to lead our QA efforts in responding to an FDA project. The ideal candidate will have a strong background in regulatory compliance, particularly with FDA regulations, and will ensure that all deliverables meet the highest quality standards.Key...

  • Quality Assurance Manager

    2 weeks ago

    Silver Spring, Maryland, United States TestPros Full time

    Job Title: Quality Assurance ManagerAt TestPros, we are seeking an experienced Quality Assurance Manager to lead our QA efforts in responding to an FDA project. As a key member of our team, you will be responsible for ensuring that all deliverables meet the highest quality standards.Key Responsibilities:Oversee the development and implementation of QA...

Associate Director, Quality Assurance

4 months ago

Spring, United States Cellipont Bioservices Full time
Job DescriptionJob Description

"Developing and Manufacturing your Cell Therapies from Benchtop to Bedside."

Job Summary

Cellipont Bioservices is growing, and we are looking for an Associate Director, Quality Assurance who believes in the potential of bridging client's discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level.


The Associate Director, Quality Assurance provides strategic oversight and leadership to QA Client liaisons and operations to ensure project objectives are met to a high-quality standard and according to commitments while ensuring current Good Manufacturing Practices (cGMPs) compliance for manufacturing of biological products, and compliance to US and EU regulations, as applicable.


The Role

  • Drives strategic projects within Quality as well as operational excellence and continuous improvement efforts
  • Ensure that the phase-appropriate systems are implemented to ensure a consistent level of quality and compliance in all processes.
  • Monitor and maintain quality systems and procedures (SOPs) for adherence to regulatory compliance requirements
  • Establish and report on key performance indicators, including the use of a compliance index, to support quality compliance awareness, initiatives, and resource allocation
  • Directs the batch record review and lot disposition activities to ensure the release of lots within prescribed timelines and in compliance with applicable regulatory submissions and approvals
  • Facilitates QA support and works closely with other Cellipont functional units including Manufacturing, Validation, Facilities Engineering, Pre-Clinical, and Quality Control to assess and resolve quality issues concerning the facility and products manufactured
  • Develop and implement procedures, programs, and policies that support GMP operations and overall compliance strategy
  • Serve as a team leader in quality investigations and ensure corrective and/or preventive action plans to resolve potential product quality and compliance issues are appropriately implemented
  • System owner of Client Audit, CAPA and non-conformance management, Risk Management and Change Control programs
  • Oversees QA Client liaison for hosting routine client audits. This includes coordinating audit support, performing facility tours, answering questions, and resolving issues. Respond to observations to ensure compliance risks are effectively mitigated
  • Participate in the Quality Metric review process, assess data for adverse trends, develop solutions, and oversee implementation
  • Responsible for staffing and overseeing training, professional development of employees, and conducting performance reviews within the group
  • Participate in facility expansion, coordinating QA support.
  • Continuous reviews of all quality systems and procedures (SOPs) for efficiency and regulatory compliance improvements.
  • Work with senior management on new client proposals and projects. This includes analyzing client proposals for resource allocation and QA costs generated by Business Development.
  • Partner with leadership and customers to drive strategic priorities with a large focus on present and future state organizational structuring and strategic planning based on growth models.

The Candidate

  • B.S. in a Life Sciences discipline- OR - M.S. in a Life Sciences discipline
  • 10+ years of relevant experience within the life sciences industry, preferably biotechnology or pharmaceuticals, performing within a Quality Assurance role
  • 8+ years of direct management experience
  • Thorough knowledge of cGMP regulations, quality systems, and regulatory requirements
  • Proficiency with electronic management systems (such as QDMS, LMS, EDMS, and E-Doc)
  • Advanced skills with MS Office applications and Adobe Acrobat
  • Experience supporting Federal government contracts is a plus
  • In-depth knowledge of Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, the USP, ICH Guidelines, and industry best practices. EU GMPs a plus.
  • Knowledgeable and/or exposed to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish. Exposure to contract manufacturing is a plus.
  • Ability to quickly learn new and novel manufacturing processes supporting new clients
  • Ability to self-direct, and adapt to changing priorities
  • Excellent communication and interpersonal skills required
  • Strong attention to detail and organization skills required
  • Proven technical writing and editing skills
  • Creative individual with excellent problem-solving and troubleshooting skills
  • Requires the ability to produce results in a fast-paced environment to meet client deadlines
  • Established leadership capabilities

Position Benefits

  • Opportunities for career growth within an expanding team
  • Defined career path and annual performance review & feedback process
  • Cross-functional exposure to other areas of within the organization
  • Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members
  • 401K strong employer match
  • Tuition Reimbursement
  • Employee Referral Bonuses
  • Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays
  • Gain experience in the cutting-edge cell therapy space



"At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our "family" approach ensures you will get the mentorship you need to develop a satisfying career here"


Notice to Agency and Search Firm Representatives

Cellipont Bioservices is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid written & signed search agreement will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.