DPS Engineering Boston , MA 02298
Posted 4 days ago
Summary
DPS Group is seeking a Compliance Specialist for a client in Boston, MA
Successful candidates will lead, write, and review deviations and investigations for the client. This includes the manufacturing, facilities, supply chain/materials management and support QC deviations as necessary.
Responsibilities
Lead, write and review deviations and investigations for the client, 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
Strong knowledge of cGMP requirements for manufacturing
Experience working in electronic Quality Management System
Demonstrated understanding of the principles and applications associated with cell and gene manufacturing operations, maintenance/calibration, engineering, and validation
Deliver On-Time Closure of Deviations to support Batch-On-Time-Delivery commitments for Tech Transfer
Skills and Qualifications
Bachelors or Advanced degree in a scientific discipline.
Experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality.
Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions.
Experience interacting with regulatory health authorities inspections.
Knowledge of global regulations and standards.
Strong team player that has a customer service approach and is solution oriented.
Attention to detail and the ability to work individually as well as within a multi-disciplinary team.
Excellent listening, communication and interpersonal skills fostering team spirit.
Consistent delivery of high-quality work at all times.
Ability to gown and work in a cleanroom environment.
Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.
Additional
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The Company
DPS Group is a global EPCMV firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a 'client-first' mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.
DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.
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DPS Engineering