SIGA Technologies, Inc. (www.siga.com) is seeking a full-time (40 hours/week) experienced Quality Assurance Specialist to join the Research & Development team in Corvallis, Oregon. This position reports to the Senior Manager, Quality Assurance and assists in the oversight of SIGA’s Quality Systems with emphasis on contractor interactions, document management, and training. As a full-time employee, the Quality Assurance Specialist is eligible for SIGA’s full benefits package including company paid medical, dental and vision benefits, short and long-term disability, life and AD&D insurance, paid time off and relocation assistance. This position may require domestic travel up to 10% of the time and is eligible for a hybrid work arrangement.

Responsibilities for this position include:

• Assist with creating and/or implementing changes to internal controlled documents (e.g., SOPs, Policies, specifications, etc.), overseeing biennial reviews of controlled documents, tracking internal training and ensuring annual GMP training is conducted
• Responsible for onsite document control of SIGA’s GXP documents/records
• Assists with scheduling consultants to ensure that contract service provider audits are conducted on a continuing basis to ensure contractors remain complaint with regulations. May co-audit GMP contract service provider, as necessary.
• Assists in conducting internal audits
• Assists in reviewing and approving contractor’s SIGA related controlled documents (e.g., master batch records, material specifications, methods, protocols, etc.)
• Assists in reviewing contractor’s executed manufacturing/packaging records and analytical data for in?process and finished products
• Assists in interacting with contractors to resolve deviations/investigations that may impact quality of product
• Assists in performing final release of manufactured/packaged products
• Interacts with SIGA’s Supply Chain department to provide batch documentation and review shipping requests for drug product shipments.
• Assists with reviewing SIGA’s current procedures/policies for compliance with cGMPs (FDA and international guidelines)
• Other duties as assigned

SIGA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, gender identity, sexual orientation, marital status, age, national origin, predisposing genetic characteristics, unemployment status or veteran’s status and will not be discriminated against on the basis of disability.

Minimum Qualifications include:

Bachelor’s degree in a scientific discipline such as Chemistry, Biology, Microbiology, or equivalent with a minimum of 2 years in a Quality Assurance role within the pharmaceutical/biotech industry

Demonstrated experience with MS Office Suite with a strong proficiency in MS Word.

Experience with electronic document management systems, auditing, and a quality certification from a national quality society is desired

The successful candidate will possess the following knowledge and abilities:

• Working knowledge of 21CFR 211, 10, ICH Q7, Q9, Q10,
• Knowledge of Health Canada, EU, UK quality regulations is a plus
• Strong, professional interpersonal skills including ability to communicate effectively with people both individually and in groups
• Experience establishing and maintaining effective relationships with business leaders and external partners
• Demonstrated ability to work independently and take initiative in scheduling and meeting deadlines
• Demonstrated success in effectively prioritizing multiple tasks and executing with a high level of accuracy and attention to detail especially in composing and proofing materials.
• Must be able to handle sensitive, confidential information with a high degree of discretion
• Must be highly self-motivated and able to manage stressful situations