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Alpha Consulting Corp. ยท 2 days ago
Process Engineer - Manufacturing Investigations
Frederick, MD
Contract
Onsite
Mid Level
2+ years exp
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Responsibilities
Complete required training to maintain technical skill, knowledge, and compliance with cGMP requirements.
Initiate quality records in the Veeva Quality Management System (QMS).
Lead cross-function team meetings to perform complex root cause analysis (RCA).
Compile investigation results in a concise and comprehensive technical report format.
Collaborate with stakeholders to develop Corrective and Preventive Actions (CAPA).
Manage investigation timelines to meet/exceed site compliance metrics for closure adherence.
Provide timely progress updates to internal stakeholders, as required.
Qualification
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Required
BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 2 years of relevant experience
AA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 6 years of relevant experience
HS Diploma with 8 years of relevant experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent
Preferred
Strong skill in technical writing
Strong skill in organization
Strong skill in root cause analysis
Experience in cell culture or aseptic processing
Experience in cGMP cell therapy manufacturing
Company
Alpha Consulting Corp.
Alpha Consulting Corp. has been exceeding expectations in the IT, pharmaceutical, and clinical staffing business since 1994.
201-500 employees
H1B Sponsorship
Alpha Consulting Corp. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (3)
2021 (4)
2020 (5)
Funding
Current Stage
Growth StageCompany data provided by crunchbase
