Job Description
Job Description
Job Title: Analytical QA Supervisor
Location: Fall River, MA
Experience Required: 5 - 15 Years
Job Type: Full-time | On-site
Shift: General (8:30 AM – 5:00 PM; flexibility required as per business needs)
Reports To: QA Manager
Job Summary:
We are hiring an experienced Analytical Quality Assurance (QA) Supervisor to join our Quality team in Fall River. The ideal candidate will bring a strong analytical chemistry background, especially within a pharmaceutical manufacturing environment. This individual will ensure adherence to laboratory compliance standards and regulatory expectations while reviewing method validations, lab protocols, and raw data.
Key Responsibilities:
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Oversee and verify method validation reports, comparisons, and study documentation.
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Monitor laboratory operations for cGLP compliance and ensure SOPs are followed.
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Review and assess standard operating procedures and test methods.
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Support the review of process validation and characterization reports.
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Coordinate with Regulatory and Lab teams for document readiness during ANDA submissions.
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Maintain accurate records, track documents, and manage archival processes.
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Review laboratory data, including audit trails, for compliance and accuracy.
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Participate in laboratory incident investigations and drive CAPA implementations.
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Review analytical documents for raw materials, in-process, and finished products.
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Conduct internal audits and enforce lab compliance protocols.
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Implement updates from Pharmacopoeial changes.
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Handle assigned cross-functional projects as per business requirements.
Required Skills & Qualifications:
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Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related discipline (Master’s preferred).
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8–15 years of relevant experience in a regulated pharmaceutical QA environment.
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Minimum 5 years specifically in Analytical QA roles within cGMP settings.
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Strong understanding of analytical instrumentation: HPLC, UV Vis, GC, pH meters, stability chambers, etc.
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Familiarity with USP monographs, FDA regulations, ICH guidelines.
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Excellent documentation, communication, and investigation skills.
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Hands-on experience with lab software, audit trails, and equipment calibration.
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Exposure to dosage forms like MDI, solids, liquids, tablets, or capsules preferred.
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Proficient in MS Office and quality management tools.
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Must be fluent in English – verbal and written.
Additional Information:
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On-site work only (remote not available).
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Relocation assistance negotiable.
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Weekend or holiday shifts may occasionally be required.
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Compliance with PPE and cGMP environment standards mandatory.
Must Have:
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Pharma industry experience (Bio-Pharma not acceptable)
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Chemistry or relevant scientific background
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QA experience in manufacturing & cGMP labs
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Strong command of English