**QA Specialist** Quality Assurance Indianapolis, IN, US Pay Rate Low: 24 | Pay Rate High: 31.25 + Added - 19/11/2024 Apply for Job **QA Specialist** **Shift** : 2nd shift Sunday-Thursday (exact hours TBD) **Location** : Greater Indianapolis area **Salary** : $55K-$65K (possibly wiggle room here for the right candidate/experience!) **Interview Process** : Phone interview, Onsite Panel, Offer **_Notes: This position is a hiring need with a January 2025 start. Looking to interview candidates the 1st/2nd week of December with a target start the 2nd week of January 2025. No interviews will take place the last 2 weeks of December._** **TOP TARGETS – Radiopharmaceutical experience in GMP is 100% MUST** + Bachelor's degree in life sciences or equivalent industry experience + 2+ years radio-pharmaceutical experience working under GMPs where documentation and strict SOP adherence are at the core of the business + Previous experience in Quality Assurance and/or with sterile drug manufacturing is desirable. + Sterile drug manufacturing + Have experience in writing SOPs and other associated GMP documentation + Proficient in Microsoft Office **Duties and responsibilities** Provide direct QA support to manufacturing through + Inspect, review documentation, and release incoming raw materials and packaging components, as need. + Issuing production related records (i.e. controlled copies) + Perform area release for manufacturing, as needed. + Review production batch records, logbooks, and associated documentation to assess completeness, accuracy, and compliance with SOPs. + Performing secondary review of documentation + Follow up on investigations and deviations related to manufacturing activities + Release/disposition GMP products for Macrocyclics and Orano Med + Scanning manufacturing batch record documentation such as batch records, raw materials, investigations, and deviations. Provide indirect QA support through + Review of equipment and instrumentation documentation in support of GMP manufacturing and testing operations. + Review of documentation related to technology transfer from R&D for manufacturing activities. + Update Quality SOP’S, as needed. + Perform directed internal audits of manufacturing and testing operations, as needed + Other duties as assigned. **Specific skills** + Bachelor's degree in life sciences or equivalent industry experience + 2+ years radio-pharmaceutical experience working under GMPs where documentation and strict SOP adherence are at the core of the business + Previous experience in Quality Assurance and/or with sterile drug manufacturing is desirable. + Sterile drug manufacturing + Have experience in writing SOPs and other associated GMP documentation + Proficient in Microsoft Office + Strong written and verbal communication skills. + Strong organization skills. + Able to easily switch between multiple ongoing projects and adjust priorities based on business needs. INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.