Quality Assurance Manager
SIGA Technologies, Inc. (www.siga.com) is seeking a full-time (40 hours/week), experienced Quality Assurance Manager to join the team at our location in Corvallis, Oregon. Under the direction of the Sr. Director of QA, the successful candidate will assist in the oversight of SIGA’s Quality systems. This position may travel domestically up to 20% of the time. Travel requirements will be dependent upon candidate skills/experience and business need.
Principal job duties include:
- Responsible for working exclusively and independently with consultants to ensure that audits are conducted on a continuing basis to ensure contractors remain compliant with regulations. Conducts internal audits, as needed
- Responsible for writing and/or implementing changes to internal controlled documents (e.g., SOPs, Policies, specifications, etc.), preforming biennial review, tracking internal training and ensuring annual GMP training is conducted
- Assists in reviewing and approving contractor’s SIGA related controlled documents (e.g., master batch records, 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
- Assists and backs-up Sr. Director, QA in providing submission ready documents to vendors and preparing/formatting files/templates to be submitted to the eCTD vendor for electronic NDA and IND
- Other duties as assigned
Minimum qualifications include:
- Bachelors degree in a scientific discipline such as Chemistry, Biology, Microbiology, or equivalent with a minimum of 7 years pharmaceutical research experience
- At least 3 years product release experience.
- Demonstrated experience with MS Office Suite with a strong proficiency in MS Word.
- Auditing experience preferable.
The successful candidate will possess the following knowledge and abilities:
- Detailed knowledge of FDA and ICH GCPs, GLPs and cGMPs
- 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.
SIGA designs and develops novel countermeasures to prevent and treat serious infectious diseases, with an emphasis on biological warfare defense. SIGA is now considered a leading drug development company in the biodefense arena. Its portfolio of existing drug candidates and its platform for developing additional countermeasures against potential agents of biological warfare are intended to fill a critical need for safe and effective treatments.
SIGA offers a challenging, dynamic environment with growth opportunity, competitive compensation and a full benefits package.
SIGA is an Equal Opportunity Employer.
Interested applicants should submit their resume and cover letter for consideration to firstname.lastname@example.org. In the cover letter, please describe your batch record review and release experience.