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Change Control Specialist - Lansdale, United States - Insight Global
Description
One of our large pharmaceutical clients is actively looking for a Change Control Specialist to join their team in West Point, PA.
This person will be owning the entire change control lifecycle process .Each change that occurs in the manufacturing process needs to be assessed and justified.
This includes technical information on the process development studies performed to support the modifications, detailed implementation tasks with associated acceptance criteria, and confirmation from all affected stakeholder groups to ensure only positive impacts.
They will be working with product components, primary packaging, or raw materials to help support the all execution.Main responsibilities include having meetings with vendors, change owners, and product owners to gather information to prepare change requests, writing & authoring memos/change control documents.
They will need to be able to read SOPS and understand the components surrounding itThese engineers will ensure the process changes are appropriately managed via the Global Change Management and IPI quality systems and will partner with technical, quality and operations stakeholders to implement the changes within a plant site and get final approval.
This is a hybrid role, 3 days onsite, 2 WFH.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day.
We are an equal opportunity/affirmative action employer that believes everyone matters.Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances.
If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to .
To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:. Required Skills & Experience2+ years' experience working within change control managementPharmaceutical industry experienceTechnical Writing & SOP writing experienceGood communication skills Nice to Have Skills & ExperienceSAP or IPIGMP pharma Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.