Scientist 2 - Specialist, Change Management Documentation

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.

ResponsibilitiesAct 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 productsActively participate in cross-functional teams to advance goals and deliverables related to the analytical change recordsGather, review, update and report routine data per GMP proceduresUtilize an electronic database to support compliant operational execution of activities related to change control, with an unwavering focus on GMP complianceEstablish good working relationships with partners across the Merck network (CMC, Quality, and QC laboratories) to ensure good communication and alignment amongst the departmentsWill be expected to identify and raise issues that may put the record behind established timelinesExpected to strive for constant system and process improvement

QualificationsBS degree in science or engineering field and 1-2 years of relevant experience, orMS degree in science or engineering field with no prior pharmaceutical experience

Required Skills and ExperiencePrevious experience in document control/change managementPrevious experience in GMP environmentMust have good project management skills and be adept in working in electronic database systems. Knowledge of analytical development in commercialization and supplyFamiliar with quality management system requirementsProven ability to work independently, displaying self-motivation, adaptability, and a positive attitudeStrong communication skills (oral and written) and attention to detailWill be required to work onsite at least 2 days per month

Desired Skills and ExperiencePharmaceutical industry experiences that focus on quality, data management, or analytical laboratory workPrevious remote work experience is a plus