Quality Specialist

Location: Remote $45-$47/HR on W2 MUST HAVE as under: • Expertise with managing deviation within customer complaints. • Anyone with CMO's and external manufacturing sites experience • Understanding regulations • Expertise with investigation and CAPA • Potential experience with inspections and audits. • Industry expertise: Pharmaceuticals/Medical device/drug products/sterile products/Combination Products. • SAP, Trackwise, Veeva Detailed job description as under: Qualifications: • Education: BA/BS/MS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) with minimum 4-6 years of relevant experience within complaints management, deviations and complaint investigations. • Previous experience within the pharmaceutical industry or Medical Devices Combination Products with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control. • Must have working knowledge of regulatory expectations for the manufacture and/or testing of pharmaceutical products and/or Medical Devices Combination Products, with experience in quality, manufacturing, process validation and/or process technology transfer processes. • Experience with Quality functions through execution of activities such as investigations, corrective actions, complaints management, quality system management, etc. Software:• Knowledge and competency with SAP and Trackwise. • Familiarity with Ariba and Veeva Vault a plus. Responsibilities: The Quality Assurance Specialist for Small molecule is responsible for management of deviations and customer complaints including coordination, review / approval of deviations and complaint investigations. Primary activities include, but are not limited to: • Review and approve deviation reports and document in Client quality systems as appropriate. • Notify External Manufacturing sites of customer complaints and internal complaints upon receipt. • Review and approve complaint investigations and document in Client quality systems. • Follow up with External Partners to ensure investigations are completed in a timely manner and escalate for support as necessary. • Collaborate with other team members to perform second person reviews of stability protocols when necessary. • Assist with reference standard requests as needed. If interested; kindly confirm with answers: Q1: How many years of exp in CMO / External Manufacturing site exp Q2: How many years of Audit and inspection exp Q3: How many years of exp in SAP, Trackwise, Veeva Q4: How many years of exp in investigation and CAPA

Created: 2024-10-29