Job Description
Insight Global is seeking a first shift (7:00am-3:15pm) Documentation Specialist to support a pharmaceutical manufacturing operation by ensuring production documentation is completed accurately, thoroughly, and in compliance with cGMP and quality standards. This individual will be responsible for reviewing batch records, identifying documentation discrepancies, maintaining document control processes, and collaborating with cross-functional teams to support compliant manufacturing operations. The ideal candidate is detail-oriented, organized, and experienced working in a regulated GMP environment.
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.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
o High school diploma or equivalent
o Minimum 3-year experience working in the pharmaceutical/biopharma/biotech industry and within controlled environments. Knowledge of manufacturing processes
o Ability to comprehend work instructions and standard operating procedures (SOP's)
o Exceptional attention to detail, accuracy, and documentation skills.
o Knowledge of cGMP and ability to follow gowning and hygiene protocols.
o Comfortable with wearing personal protective equipment (PPE) such as gowns, gloves, and masks.
Nice to Have Skills & Experience
- additional technical or vocational education
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.