Ambrx Inc., is a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code. Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into protein, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next-generation antibody drug conjugates (ADCs), bispecifics, and targeted immuno-oncology therapies for cancer as well as smart cytokines to modulate the immune system, and long-acting therapeutic peptides for metabolic and cardiovascular disease.
We are seeking a highly motivated and experience Quality Assurance Document Control Manager to join our fast paced and growing Quality Team. The QA Document Control Manager will manage documents (both electronic and paper copies) within Quality Assurance, Regulatory Affairs, Clinical and other key departments to ensure that all GxP regulated documents are filed systematically and are easily retrievable. The candidate is primarily responsible for the implementation, management and maintenance of the document management system in accordance with the Quality System and relevant regulatory requirements. This position is also responsible for training staff on document control processes and procedures. In addition, the QA Document Control Manager will manage both paper and electronic records to ensure that controlled records are created, identified, changed, reviewed, retained, stored, and maintained in a manner that meets requirements.
Essential Duties and Responsibilities (including, but are not limited to):
- Receive, file, and maintain all GxP documents, including but not limited to standard operating procedures (SOPs), test methods, specifications, incident reports, CAPAs, computer system validation, …etc.
- Assist in the selection and implementation of an electronic quality management system (eQMS).
- Manage a Document Repository that tracks the receipt, revisions and archiving of all GxP documents; and prepare supportive process workflows and procedures to maintain efficiency and access for all users.
- Maintain GxP audit files and assist with entry, tracking, and archiving of audit records.
- Oversee and administer document lifecycle management as well as the change request process.
- Assist in the maintenance of training records and documentation within our system.
- Assist with and/or write SOPs for the creation and development of processes, archiving, and operations related to Document Control and other functions.
- Perform review of documents submitted through the change control process for format, completeness, review and approvals.
- Provide guidance and training to staff regarding document control processes.
- Maintain overall document control structure within the document management system.
- Define and maintain user roles and permissions in the document management system.
- Resolve electronic document management system problems and issues in collaboration with users, system vendors and IT.
- Support development of system and process improvements that would enhance compliance to documentation/training requirements.
- Bachelor’s degree in Science or similar required.
- >4 years of experience in a regulated environment and experience in managing and administering document control systems.
- Knowledge of quality systems and regulatory compliance requirements within pharmaceutical or biotech environment.
- Excellent interpersonal skills, with ability to interact effectively and work efficiently with people at all levels in an organization.
To be considered for this opportunity, please submit your resume/CV referencing the position code to firstname.lastname@example.org. Applicants whose qualifications and experiences most closely match the requirements will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensations & benefits. EOE.