Princeton Junction, NJ, United States
Quality, Chemistry, Compliance
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.
Work Location: New Haven, CT
Job Title: Quality Assurance Compliance Specialist IV
Duration: 6 months (extendable) contract on W2
Receive and process requests within the company eDMS for controlled document creation, changes, or withdrawal (Document Control, Change Requests).
Maintain tracking and processing of controlled documents relating to company Periodic Review process.
Maintain the system for records and retention using a standard categorization system in accordance with internal and regulatory requirements.
Receive and respond to requests for Quality Documents / Records / Revision History during internal and/or Regulatory Audits.
Track and maintain metrics for Periodic Review and all other departmental metrics.
Collaborate with Training/Learning function to ensure proper assignment of training requirements for controlled document updates and/or new releases.
Conduct instructor led trainings for Document Management procedures and routinely consult with internal customers to answer questions, resolve technical issues, and to ensure priorities are met.
Create and distribute Lab notebooks, binders, and other critical documentation in accordance with internal procedures and cGMP, cGLP.
Reference and take involvement in company Deviations, Corrective and Preventive Actions (CAPAs), and Risk Assessments as it relates to Document Control procedures.
Work as part of a team to manage changing priorities, complete tasks, and meet deadlines. Other assigned projects as needed.
9 Years of Experience
Minimum of 7 years GMP related experience in biopharmaceutical / pharmaceutical or related industry.
Experience in developing, implementing, and evaluating archives or records management processes and systems. This includes cataloging, filing, and retrieving of records.
Experience with GMP global regulatory requirements.
Experience with electronic systems (e.g. FirstDoc and TrackWise) and databases. Capable of moving, copying and recovering large numbers of files and folders in a Windows environment.
Knowledge of the creation and management of records retention schedules
Knowledge of archival metadata and metadata management
Ability to work in a fast-paced environment
Performs a variety of tasks
BS/BA degree in Chemistry, Biology or related field.
Recruitment Manager - IT
Direct: 609-285-3977 Fax: 609-228-4079
600 Alexander Rd, Suite 3-3
Princeton Junction , NJ 08540
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