Quality Specialist
3 weeks ago
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
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