Job Title: Process Expert Duration: 6 months Location: Indianapolis, IN, 46268, (Mon-Thurs, 1st Shift)
Description: As a Process Expert you will provide front line support to manufacturing, working with the production team to ensure each batch is manufactured safely and in compliance with the batch instructions and quality requirements. You will act as our Subject Matter Expert(SME) for product and process knowledge and will be the first point of contact for product and process related issues. Drives investigations to true root cause, and implementation of corrective and preventive actions.
Key Responsibilities: • Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols,and other documentation as needed. • Technical writing/Reviewing to support manufacturing operations including but not limited to, Standard Operating Procedures(SOP), batch records and white papers. • Collect data for ongoing process verification (OPV), support tracking and evaluation of product performance and implementation of CAPAs. • Authoring/Owning investigations related to material transfer, API synthesis, Drug Substance formulation, Drug product filling, inspection, and packaging. • Ensure processes are always inspection ready. • Support process optimization and new technology introduction for continued productivity improvement, as appropriate. • Review validation protocols and reports. Support the execution of process validations, and short-term improvement projects. • Provide guidance and support to production team through training and knowledge sharing. • Will demonstrate leadership capabilities and guide processes to closure/completion, while following all required guidelines and procedures.
Role Requirements • Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry or relevant experience in lieu of degree. • 3 years’ experience in a process support shop floor role in GMP manufacturing and/or QA/QC. • Proven process understanding (Pharma, GMP, Regulatory aspects). • Strong awareness of quality issues. Compliance investigations experience required. • Excellent technical writing skills
Desirable Requirements: • Previous Radio pharma experience a plus • Prior leadership and/or high cross-functional experience preferred.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $35.00/hr.
