Description
JOB SUMMARY
Support quality systems as they relate to the manufacturing and testing of cGMP drug products. These duties will include, but will not be limited to: providing oversight and support to the deviation and CAPA systems with process or system level knowledge, SOP creation and revision, review of quality documents, and supporting the Quality Management System. Actively participate in cross functional teams to support quality investigations.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Process Owner for QA systems, including CAPAs and Deviations associated with operational processing and batch release. Generate status reports and monitor completion.
- Train users on NCR/CAPA System processes.
- Perform triage and impact assessment for deviations. Review and approve minor/no impact non-conformances.
- Work with and coach Specialists in support of GMP documentation.
- Maintain an understanding of the changing cGMP environment, company SOPs, and industry best practices.
- Perform tasks within the quality systems with a demonstrated understanding of the correlation between systems.
- Provide back-up support for the review and approval of Quality Assurance required signatures for controlled documentation (e.g. SOPs, studies, reports, etc.).
- Perform review and approval of QC Analytical/Micro Laboratory Investigations.
- Open to a flexible and fluid work environment.
- Support Agency, customer and vendor audits as needed.
- Interact with customers to support client initiatives.
- Identify and lead complex continuous improvement efforts.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Identify and lead complex continuous improvement efforts.
- Perform all other tasks, projects, and duties as assigned.
Requirements
DESIRED SKILLS AND ABILITIES
- Ability to complete tasks with accuracy and efficiency.
- Ability to interpret and relate quality standards for implementation and review.
- Portrays appropriate levels of integrity and professionalism.
- Excellent written and verbal skills; Ability to communicate effectively with management and staff.
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Results oriented and efficient.
- Creative and open-minded individual who fosters an environment in which sharing of ideas is encouraged.
- Demonstrates confidence in decision making ability and assessing risks.
- Work independently and in a cross-functional team environment under minimal supervision.
- Must have proficient computer skills in Microsoft Word, Excel and Outlook.
Qualified candidates have knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
Level II: This level of knowledge is normally acquired through completion of a Bachelor's Degree in Life Sciences or related field, and 2-5 years related work experience. In lieu of a Bachelor's Degree, equivalent GMP/related work experience may be considered.
Level III: This level of knowledge is normally acquired through completion of a Bachelor's Degree in Life Sciences or related field, and 4-8 years related work experience.
GRAM supports Equal Opportunity Employment
