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Company Contact Info
- Holden, MA 01520
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QA Specialist - Pharma
Experis • Holden, MA
Posted 2 months ago
Our client in Holden, MA has a 6 month contract role for a QA Specialist.
Must have Pharmaceutical industry QA experience.
- Will be responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP support of the manufacture, testing and release of product.
- May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.
- Perform all responsibilities in a compliant manner in accordance with company policies, procedures, federal regulations, and safety requirements.
- Review manufacturing batch records to certify compliance with specifications and procedures and completes required documentation for batch disposition.
- Manage training compliance activities and interface with the documentation control system Reviews incoming materials for compliance to specifications, determines release status.
- Provide on the floor support for Manufacturing, including EWH (Egg White Harvest and PPU operations)
- Work closely with Manufacturing, Facilities, and Quality Control to resolve open issues resulting from record reviews, on the floor walk through activities of the facility, and deviation issues.
- Work with all departments to ensure timely review and completion of Deviations, CAPA, Change Controls, Investigations and Environmental Excursions.
- Input information from the Quality Systems into electronic databases and generating reports from these systems.
- Capture and report metrics around Quality Systems and Batch Record review turn-around times and closure/approval times.
- Facilitate timely and accurate archiving of GMP documentation
- Interact professionally and works collaboratively with company management, internal departments, and other sites to effectively implement and maintain Quality Systems and shared objectives.
- Support and participate in external and internal audits as required.
- Participate in various project and technical meetings, as needed.
- Collaborate with teams to ensure efficient, compliant, and timely review and closure of GMP documents.
- Maintain working knowledge of manufacturing processes, validation, and change control concepts for pharmaceutical manufacturing
- Must be able to exercise judgment within defined practices and policies to determine appropriate action to be taken.
- Possess a strong attention to detail, planning, and organizational skills, with flexibility for changes in work priorities to plan and accomplish goals.
- Use a team-oriented approach to problem resolution with an ability to work independently and collaboratively in a team structure.
- Ability to work at the network level supporting Transgenic Operations
- Minimum of 2 years direct Quality experience.
- Minimum of 2 years GMP related experience in biopharmaceutical / pharmaceutical or related industry experience
- BS/BA degree in Chemistry, Biology or related field.
- Must have experience with GMP, INTERNAL AUDITS, QUALITY ASSURANCE, BATCH RECORDS, CAPA, DOCUMENT CONTROL, DOCUMENT MANAGEMENT, MITIGATION, PROCESS IMPROVEMENTS, and QUALITY SYSTEMS
Experis is an Equal Opportunity Employer (EOE/AA)