ImaginAb is an emerging immune-oncology imaging company developing a pipeline of novel products that give physicians unprecedented insights into the patient’s health—enabling better patient selection and treatment monitoring for immuno-oncology therapies and other drugs.
Harnessing the specificity of monoclonal antibodies, ImaginAb designs and engineers small, highly targeted proteins known as minibodies that image important molecular targets using standard Positron Emission Tomography (PET).
Our imaging tools help physicians answer important clinical questions, improving the path of care and ultimately helping patients live longer, healthier lives.
POSITION: QUALITY ASSURANCE SPECIALIST
The role of the Quality Assurance Specialist is to review and monitor validation/qualification packages for completeness and accuracy, sound rationale, regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. In this position, you will formulate and recommend quality assurance (QA) policies and programs, be responsible for the disposition of the Bulk Drug Substance, Drug Product Intermediate, and Final Drug Product on all the ImaginAb programs and support the CMO’s audit program.
- In partnership with the technical teams, establish quality programs to:
- Monitor validation activities and conduct risk assessments.
- Manage GMP material control program including labeling and storage conditions of different stage of the products.
- Oversee component and finished product stability program.
- Support of methods Qualification/ Validation for release testing.
- Processes, dates, issues, and tracks batch record and other documentation.
- Assures finished products conform to government and company standards and satisfies GMP regulations.
- Ensures the accuracy and completeness of the QA document system, performs daily filing, organizes contents, and revises the table of contents.
- Maintain and improve the QMS system and training file for each employee working under GMP.
- Act as reviewer and auditor for operational SOP’s, Work Instructions, and vendors, including any follow-up; may assist in writing SOPs if needed.
- Reviews and approves Technical Research and Development reports and other documentation prepared by QA and QC for regulatory submissions/inspections.
- Responsible for the development of Quality Agreement with both internal and external partners.
- Bring critical exceptions or deviations to management’s attention and initiate and implement necessary improvements and corrections to established systems and processes.
- Initiate, execute, and track completion of Change Control, Non-Conformance, and CAPA requests.
- Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
- Support Vendor Evaluations from System Compliance perspective.
- Providing input into the development of annual audit plans (systems audits) for assigned areas/group using risk assessment methodology.
- Supporting evaluation of computerized systems controls at Contract Research Organizations and Functional Service Providers.
- Supporting regulatory inspections of ImaginAb, clinical investigator sites and service providers.
Skills, Education and Experience:
- Bachelor’s degree and 3 years of Quality and/or Validation experience in the Biotech and/or pharmaceuticals industry OR
- Associate’s degree and 5 years of Quality and/or Validation experience in the Biotech and/or pharmaceuticals industry
- 3 years in biopharmaceutical industry with 2 years working in GMP manufacturing or quality assurance experience (electronic quality management system experience [eQMS] preferred)
- Detailed knowledge and application of GMP, GDP and GCP requirements
- Knowledge of and interest in developing an electronic QMS; a keen interest in technology and a willingness to embrace new standards
- Experience supporting regulatory authority inspections
- Participation in process improvement initiatives
- Knowledge of audit/compliance program design and audit methodology
- Demonstrated problem solving abilities
- Contributes to work group/team by ensuring quality of tasks/ services provided by self and others
- Develop and foster positive working relationships with colleagues and service partners
- Communicate effectively and ability to function well in a team environment
- Excellent written and oral communication skills
- Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
Physical and Mental Requirements / Work Environment:
- The mental and physical demands, and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
- Remaining in a stationary position, often sitting for prolonged periods in an indoor office environment.
- Must be able to access and navigate throughout various offices of the building.
- Communicating with others to exchange information and perform duties: talking/hearing/writing/typing
- Ability to read materials in paper format and on a computer screen
- Repeating motions that may include the wrists, hands and/or fingers
- Specific vision abilities required by this job include close vision and ability to adjust focus.
- Ability to read, analyze, and interpret general professional journals, technical procedures and governmental regulations. Ability to write reports, business correspondence, and procedural manuals.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Moderate noise level consistent with an office environment
Salary and Benefits:
Salary commensurate with experience. ImaginAb offers a generous health benefits subsidy, long-term disability, 401(k), Employee Assistance Plan, tuition reimbursement, and paid holidays and time off.
Partial remote work from home. Candidates must be local and available to work on premises full-time post COVID-19.
ImaginAb is currently unable to facilitate visas for non-US citizen/resident applicants. No relocation assistance is offered for this position.
How to Apply:
If you are interested in exploring this challenging and rewarding opportunity, please forward your cover letter and resume to ImaginAbHR@everybizhr.com
All expressions of interest are considered in confidentiality. We thank all applicants who apply, but only those candidates selected for an interview will be contacted.
ImaginAb is an equal opportunity employer.