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Recipharm · 2 days ago
Specialist II, Quality Assurance Operations
Watertown, MA
Contract
Onsite
Mid, Senior Level
5+ years exp
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Responsibilities
Provide on-the-floor QA support for manufacturing activities by being present during the manufacturing runs and reviewing production documentation real time on the floor.
Issue production batch records, solution buffer records, test record and product labels to support manufacturing activities.
Support cGMP manufacturing operations through administration and enforcement of the Quality Management System including, but not limited to, deviations, change controls, and CAPAs.
Review and approve master batch records.
Perform the review and approval of product testing and environmental monitoring data.
Review and approve room cleaning documentation including environmental monitoring testing data to conduct room releases.
Review, assist in the investigation of environmental excursions.
Represent Quality Assurance on project teams and in meetings.
Support the continuous improvement and oversight of Quality Operations procedures.
Qualification
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Required
BS required, MS preferred in a scientific/technical discipline with 5+ years of experience in a QA position within the biological and/or pharmaceutical industry
Ability to apply GMP regulations and international guidelines to all aspects of the position
Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy
Exceptional oral and written communication skills to all organization levels as well as clients and vendors
Strong organizational skills; able to prioritize and manage through complex processes/projects
Ability to write reports, business correspondence and SOPs
Ability to be hands-on and detail orientated
Very proficient in MS Office application suite as well GMP electronic applications
Effectively manages cross-functional communication
Multitasks, strategically and tactically in a fast-paced work environment
Strong organizational skills; able to prioritize and manage through complex
Ability to define problems, collect data, establish facts, and draw valid conclusions
Detail-oriented and highly motivated with excellent written and verbal communication skills required
Ability to work independently and stay on task in a fast-paced environment
Ability to function in a rapidly changing environment and balance multiple priorities simultaneously
Bending, standing, walking, lifting, sitting, carrying, repetitive motions typing- filing – writing
Ability to lift and carry 10 pounds
The ability to gown and work successfully in a manufacturing environment
Company
Recipharm
Recipharm focused on supporting pharmaceutical companies in taking their products from early development to manufacturing.
5,001-10,000 employees
Funding
Current Stage
Public CompanyTotal Funding
$241.75M2016-01-27Post Ipo Equity· $32M
2014-09-19Post Ipo Debt· $209.75M
2014-04-04IPO· sto:RECI-B
Leadership Team
Marc Funk
CEO
Kenth Berg
SVP - Business Management
Recent News
2024-06-04
2024-05-23
Company data provided by crunchbase
