Responsibilities
One of our largest pharmaceutical clients is seeing a Deviations Writers to join their team. The role will be onsite in Durham 3 days a week, with 2 days a week remote. This is in support of one of the fastest growing drugs at the plant and is critical to the success of manufacturing at the site. This area has two duplicate large scale purification processes, a fermentation process, and a sterile supply area. Different systems will be in different phases of the tech transfer, from commissioning to manufacture of our first GMP batches. As mentioned below, it is supporting the Deviation Management, Change Control, and Technical Operations workstreams. Depending on the skills and experiences of the candidates, you can either be dedicated to one workstream or splitting their time between multiple workstreams. The successful candidate will be detail oriented, can complete multiple simultaneous deliverables with established deadlines, and an ability to pick up new systems and processes. This is an excellent opportunity for you to get your foot in the door from the start of production.
* Author Atypical Investigations to support vaccine manufacturing
* Develop and implement corrective and preventive actions
* Author Change Controls to assess vendor changes to raw materials and components
* Author technical protocols to support sampling, shipping, receiving, validation, manufacturing, or process development activities
* Attend and communicate progress at weekly Tier meetings
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
HR@insightglobal.com.
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Benefit packages for this role will start on the 1st 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.