Quality Assurance Specialist III/Senior
Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.
Precigen has developed novel manufacturing processes to deliver UltraCAR-T® and AdenoVerse™ immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies.
In support of these efforts, Precigen is seeking a detail oriented and skilled Quality Assurance Specialist III/Senior (level determined by experience) to work with our Quality Assurance team. This role will support Quality Systems and perform QA operations tasks, fulfil QA responsibilities for the cGMP functions within Precigen. The position works to ensure compliance to applicable regulations and company procedures/policies.
This will be an onsite role in our Germantown, Maryland facility.
DUTIES AND RESPONSIBILITIES:
- Execute specific tasks and fulfil responsibilities of the Quality Unit, including review of executed records, inspect/audit for SOP compliance, review/release of materials, perform line clearance activity, etc.
- Work with QA staff on Quality System development and improvement initiatives.
- Promote and ensure Quality and compliance within Precigen.
- Perform additional duties as assigned by supervisor.
EDUCATION AND EXPERIENCE:
- BS/BA degree in a scientific/life sciences discipline.
- Minimum three (3) years of progressive QA experience in a pharma/biotech environment.
- Knowledge of principles and practices of cGMP.
- Experience in QA support of biologics manufacturing; experience in Gene Therapy and/or Cell Therapy is a plus.
DESIRED KEY COMPETENCIES:
- Ability to understand and execute on the company’s mission and values.
- Exceptional organization skills with strong attention to detail.
- Strong interpersonal skills including clear communication in both oral and written form.
- Demonstrated ability to work with and coordinate demands from multiple stakeholders.
- Exhibition of the highest degree of ethical standards and trustworthiness.
- Thorough understanding and use of Microsoft Office Suite and Adobe Acrobat Pro.
- Ability to learn then administer automated quality systems.
- Responsive, can-do attitude.
- Deals with conflict in a direct, positive manner.
- Ability to think and adapt to a rapidly changing environment and demands.
Precigen, Inc. is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cellular therapies to target the most urgent and intractable challenges in immuno-oncology, autoimmune disorders and infectious diseases. We invite you to discover more at www.precigen.com.
Precigen, IncGermantown, MD
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