Job Description
- ADQC Compliance Specialist is responsible for performing assigned administrative tasks while maintaining the highest standard of quality and compliance in ADQC and the Clinical QC (GMP) laboratories.
- This candidate will be responsible for administrative duties such as data archival, ALCOA+ documentation management, assurance/adherence to local GMP procedures, initiation and support of change controls, deviations and investigations (as applicable) relevant to ADQC biologic and gene therapy programs.
- Additionally, this candidate will be assisting the CQC Compliance team with the Clinical QC periodic review process, equipment qualification program and EQV system, ensuring quality requirements are met per procedure and performing relevant assigned compliance tasks as assigned.
- Perform all job functions in compliance with cGXPs and maintain accurate and legible laboratory records
- Responsible for generating, reviewing, and providing assessments for Quality records for Analytical Development and Quality Control (ADQC) ensuring compliance with regulatory standards, maintaining of data integrity, and optimizing system performance
- Track and present schedules internally for compliance related events in ADQC (Periodic reviews, system qualification and validation activities, guidance document updates, system obsolescence and upgrade needs etc.)
- Compliance involvement for laboratory investigation reports, deviation reports, CAPAs
- Provide backroom assistance for Quality audits
- Conduct reviews of new procedures and proposed changes to current procedures for compliance with regulatory and corporate requirements
- Assist compliance team with equipment maintenance and management as needed.
- Strong verbal communication and presentation skills
- Create plans and present timelines to meet established targets, goals and objectives
- A successful candidate will have a minimum of BS/BA degree in a relevant field with 2-5 years of experience working in cGMP setting
- Knowledge of Pharmaceutical Quality Assurance, regulatory compliance and/or quality control inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
- Strong working knowledge of Microsoft suite programs
- Effectively organize and manage work responsibilities. Excellent time and project management skills with the ability to multi-task.
- Strong proficiency in quality management systems and audit procedures.
- Strong and effective communication skills for interacting with cross-functional teams.
- Mental Acuity: High attention to detail and ability to maintain accuracy in documentation and processes. Strong analytical and problem-solving skills with the ability to conduct risk assessments and root cause analysis.
- Physical Requirements: Ability to bend, reach and stand, with lifting up to 15 pounds and carry over short distances
- Working knowledge in validated documentation systems: Veeva Vault (EQV), LIMS, ValGenesis, Kneat, etc.
- Knowledge of pharmaceutical/biotechnology manufacturing process
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