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Job Title
Scientist 2 - Specialist, Change Management Documentation
Company
PAREXEL International Corporation
Job Description
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We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it
With Heart
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Scientist 2 - Specialist, Change Management Documentation
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Job ID
R0000007732
Northeast, New Jersey, United States of America
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
We are looking to fill a Scientist 2 - Change Management Documentation Specialist
position working as a full-time employee of Parexel FSP on long-term assignment
onsite at one of our clients located in Hybrid Remote – Rahway, NJ or West Point, PA.
This position offers full benefits, sick time, 401K, paid holidays, and paid time off. If interested, please send a copy of your resume to
Kaitlyn Weiss – kaitlyn.weiss@parexel.com
. This position does not offer any sponsorship.
Description -
Global Change Management Records Specialist supporting analytical changes for internal and external sites for APIs and DPs. This group specializes in change management activities in support of the technical organization, including but not limited to, authoring and end to end ownership of change control records, individual support on setting change control strategy, training and user qualification among others.
Responsibilities
Act as a change owner for analytical change records, including but not limited to method and specification updates, compendial amendments and equipment/site changes for APIs, intermediates, and drug products
Actively participate in cross-functional teams to advance goals and deliverables related to the analytical change records
Gather, review, update and report routine data per GMP procedures
Utilize an electronic database to support compliant operational execution of activities related to change control, with an unwavering focus on GMP compliance
Establish good working relationships with partners across the Merck network (CMC, Quality, and QC laboratories) to ensure good communication and alignment amongst the departments
Will be expected to identify and raise issues that may put the record behind established timelines
Expected to strive for constant system and process improvement
Qualifications
BS degree in science or engineering field and 1-2 years of relevant experience, or
MS degree in science or engineering field with no prior pharmaceutical experience
Required Skills and Experience
Previous experience in document control/change management
Previous experience in GMP environment
Must have good project management skills and be adept in working in electronic database systems.
Knowledge of analytical development in commercialization and supply
Familiar with quality management system requirements
Proven ability to work independently, displaying self-motivation, adaptability, and a positive attitude
Strong communication skills (oral and written) and attention to detail
Will be required to work onsite at least 2 days per month
Desired Skills and Experience
Pharmaceutical industry experiences that focus on quality, data management, or analytical laboratory work
Previous remote work experience is a plus
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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