Deviations Specialist (Pharmaceutical)
Boston (Seaport), MA
Summary
ADPS Engineering is looking for a Manufacturing Deviations Specialist to provide investigation and compliance support to the Pharmaceutical Manufacturing Facility. The ideal candidate will perform complex root cause analysis, work with stakeholders to identify corrective and preventative actions, ensure the Manufacturing Technology team is audit ready, facilitate Annual Product Quality Reviews, and investigate product complaints. The Deviations Specialist reports to the Senior Manager, Manufacturing Technical Services within the Manufacturing Technology department.
Responsibilities:
Responsibilities:
- Lead, write and review deviations and investigations for VCGT, including the manufacturing, facilities, supply chain/materials management and support QC deviations as necessary.
- Identify and assemble proper SMEs for triage, determine immediate actions taken, document impact assessments, lead RCA, develop appropriate CAPAs
- Author and review SOPs, policies and batch production/testing records to ensure compliance and adherence to regulations/cGMP operations.
- Closely partner with peers for rapid review of batch-related documentation.
- Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
- Monitor process operations to ensure compliance with specifications.
- Assist in the investigation of procedural deviations.
- Oversees execution of CAPAs, deviations and change controls in support of PCV manufacturing.
- Reviews minor manufacturing deviations.
- Develop batch records, SOPs and training materials as needed.
- Demonstrate a general knowledge of standard manufacturing compliance, quality disposition, and quality system review.
- Utilize knowledge to improve operational efficiency.
- Participate in quality oversight of manufacturing through real-time observations of activities.
Skills & Education
- At least 3-4 years of QA or Manufacturing experience in a GMP manufacturing environment with a Bachelor’s Degree in Biology, Chemistry, Chemical engineering, Biomechanical engineering, Bioengineering, Biomedical Engineering, Biochemistry or related field.
- Proven track record of success in a fast-paced production environment at a biotech/pharmaceutical company preferably in GMP or GLP
- Ability to collaborate fluidly with peers, supervisors and cross-functional support groups required
- Proficiency in writing deviations
- Exceptional written, oral communication, and organizational skills required
- Demonstrated understanding of the principles and applications associated with cell and gene manufacturing operations, maintenance/calibration, engineering, and validation
- Must be able to work under general direction to plan, coordinate, and ensure completion of engineering team deliverables.
- Experience working in an electronic Quality Management System
- Effective verbal and written communication skills.
- Excellent interpersonal, teamwork, and leadership skills required.
- Participates in determining objectives of assignment and plans, schedules and arranges own activities in accomplishing milestone achievements.
