Senior Quality Assurance Specialist
ImaginAb is a precision medicine company based in Inglewood, Los Angeles, California. Our mission is to transform the clinical management of cancer and autoimmune diseases via targeted molecular imaging. We engineer our minibody technology against biologically important targets, optimized for diagnostic imaging with 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: Sr. Quality Assurance Specialist
The Sr. Quality Assurance Specialist position is responsible for Quality Assurance GCP/GMP activities to ensure quality and compliance of ImaginAb and partners clinical trials with respect to applicable GCP & GMP regulations (e.g., FDA, EU, country-specific), ICH GCP guidelines, ImaginAb’s Standard Operating Procedures (SOPs), and current industry standards and practices. Activities will generally fall under the following areas: GCP/GMP QA audit program, quality system, and internal / CMC and clinical study team support.
In this position, you will formulate and recommend quality assurance policies and programs, be responsible for the disposition of the Drug Substance, Drug Product Intermediate and Final Drug Product on all the ImaginAb’s compounds and be responsible for the CMO’s audit program.
This role will take a leadership position in managing other QA staff and QA projects, and partner with other ImaginAb staff to contribute towards group and quality goals.
- Serves as QA project lead, and in partnership with the technical teams, establish quality programs to:
- Monitor validation activities and conduct risk assessments.
- Manage GMP material control program including labeling, transport 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 satisfy GMP regulations.
- Ensures the accuracy and completeness of the QA document system, performs routine filing, organizes contents, and revises the table of contents.
- Support regulatory inspections, internal audits, and external audits from partners
- Acts as an analytical QA subject matter expert in support of regulatory inspections and internal audits.
- May conduct or serve as a lead/coordinator of investigations and corrective/preventative actions
- Establishes 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 and Non-Conformance requests related to computer systems.
- 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 audit plans (systems audits) for assigned areas/group using risk assessment methodology.
Skills, Education and Experience:
- Master’s degree and 3 years of Quality and/or Validation experience in the Biotech and/or pharmaceuticals industry OR
- Bachelor’s degree and 5 years of Quality and/or Validation experience in the Biotech and/or pharmaceuticals industry
- 3-5 years in biopharmaceutical industry with 3 years working in GMP regulated manufacturing environment
- Detailed knowledge and application of GMP, GDP and GCP requirements
- Self-driven, results-oriented with a “can do” positive attitude
- Experience supporting regulatory authority inspections
- Participation in process improvement initiatives
- Knowledge of audit/compliance program design and audit methodology
- Knowledge of and interest in developing an electronic QMS; a keen interest in technology and a willingness to embrace new standards
- 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
How to Apply:
If you are interested in exploring this challenging and rewarding opportunity, please forward your cover letter and resume to email@example.com.
ImaginAb is an equal opportunity employer. We offer a competitive salary along with providing health, dental, vision, life insurance, and 401K benefits to full-time employees.
ImaginAb is currently unable to facilitate visas for non-US citizen/resident applicants. No relocation assistance is offered for this position. 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.