The Quality Assurance (QA) Specialist will be responsible for assisting in the oversight of laboratory analyses and operations as they relate to QA. This key functional role will operate within a cross-functional GXP QA Team and supports internal QA functions. This position will be responsible for reviewing and maintaining cGMP analytical documentation, interacting with manufacturing vendors and analytical contract labs and assist in the conduct of external and internal audits. The QA Specialist shall provide oversight to ensure compliance with company policies and procedures, ICH, FDA and EU requirements, cGMP, and other applicable requirements.
Essential Duties and Responsibilities (including, but are not limited to):
- Participate on project teams and/or specification development teams, serving as the QA representative and escalate issues to senior QA management when appropriate.
- Review and assess API, drug and finished product(s) analytical records for clinical and commercial products in a timely manner.
- Provide guidance and training to staff regarding analytical data review, method validation as well as other quality processes.
- Facilitate the change control process, oversee and manage change controls for changes made to specifications, stability or validated methods for commercial products.
- Review and assess stability data supporting retest period and assign retest dates for clinical products.
- Maintain tracking logs for quality systems.
- Facilitate and/or assist in audits of external vendors.
- Perform, track and report internal audit information for all areas of GxP compliance.
- Write SOPs for the creation, development or improvement of processes related to quality systems.
- Prepare reports for management review of key statistics such as documentation review and internal audits.
- Other essential duties as assigned.
- Knowledge of quality systems and regulatory compliance requirements within a commercial drug manufacturing operation is necessary. Experience with domestic and/or international drug development and approval process is desired.
- Must possess an awareness of the relationship between sponsor companies and contract manufacturers.
- Attention to detail, critical thinker and effective organizational skills required.
- Strong communication and proficient soft skills.
- Works well in a team environment with the ability to drive results.
- Ability to solve problems and work collaboratively in a team environment.
- A basic understanding of GLPs and GCPs is desired.
Education and/or Experience:
- B.S. Degree in Chemistry, Biology, or related field.
- A minimum of 5 years of experience within the pharmaceutical or biotechnology industry.
- Relevant experience and knowledge of analytical analyses for the small molecule pharmaceutical industry is desired.
- Experience with electronic laboratory systems is desired.
- Previous experience with quality systems and in conducting external audits.