- Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
- The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
- We are seeking a highly motivated individual to join us as a Quality Systems Document Control Specialist.
- Implement quality systems associated with Document Management with a focus on batch record and label issuance.
- Work closely with SMEs to execute workflows and business processes that align with best practices that ensure right first time.
Responsibilities (include but are not limited to):
- Maintain a document management system compliant with regulatory, quality, and company requirements.
- Responsible for the management of all documentation and records issuance and archival processes to support clinical and commercial manufacturing.
- Provides guidance and advice on approved procedures, standardization and requirements associated with the document management system.
- Responsible for maintaining the document change control system.
- Executes the document change process so that only approved and validated changes are incorporated into effective product and process documentation.
- Ensures accuracy by reviewing documents for completeness, proper authorization and impact to other quality systems.
- Collaborates with cross-functional departments to ensure timely implementation of document change requests.
- Support audits (internal, external) in order to verify that regulatory and quality requirements have been met.
- Perform other duties as required.
- Bachelor’s Degree.
- Minimum 5 years of experience in a quality document management, quality engineering, validation, and quality assurance or quality systems.
- Strong knowledge of GMP, SOPs and quality system processes.
- Excellent organizational skills and ability to review processes or procedures.
- Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic document management systems (Document Locator, documentum, Veeva or equivalent).
- Strong written and verbal communication skills.
- Ability to communicate and work independently with scientific/technical personnel.
- Experience in pharmaceutical or bio-pharmaceutical field.
- Education or training in cell culture and gene therapy manufacturing environment a plus.
- Quality systems demonstrated working knowledge in areas such as document management, document change control audits, batch record and label issuance.
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
- The standard work week for this position is Tuesday – Saturday or Sunday -Thursday.