Senior Quality Assurance Specialist

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 Senior Quality Assurance Specialist to work with our Quality Assurance team. This role will support Quality Systems and perform QA operations tasks 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 responsibilities of the Quality Unit, including review of executed records, inspect/audit for SOP compliance, review/release of materials, support document control functions, etc
• QA lead for Precigen’s external clinical manufacturing activities
• 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.
• Knowledge of principles and practices of cGMP
• Experience with interaction/management of clinical manufacturing sites
• Experience in Cell Therapy is desired

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
• Upon hire to this position Precigen will require documentation of a COVID-19 vaccination or exemption for medical or religious reasons

EOE MFDV
WORK ENVIRONMENT
Administrative office/cubical; some laboratory/cleanroom access

• Frequent: Speaking; hearing; sitting; use of hands/fingers; handling or feeling objects, tools or controls; close vision; color vision; peripheral vision; ability to adjust focus
• Occasional: Standing; walking indoors; reaching with hands and arms; stooping; kneeling; crouching; lifting and/ or move up to 10lbs
• General: Moderate noise level, similar to typical office environment with computers, printers and light traffic