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:
Oversee and verify method validation reports, comparisons, and study documentation.
Monitor laboratory operations for cGLP compliance and ensure SOPs are followed.
Review and assess standard operating procedures and test methods.
Support the review of process validation and characterization reports.
Coordinate with Regulatory and Lab teams for document readiness during ANDA submissions.
Maintain accurate records, track documents, and manage archival processes.
Review laboratory data, including audit trails, for compliance and accuracy.
Participate in laboratory incident investigations and drive CAPA implementations.
Review analytical documents for raw materials, in-process, and finished products.
Conduct internal audits and enforce lab compliance protocols.
Implement updates from Pharmacopoeial changes.
Handle assigned cross-functional projects as per business requirements.
Required Skills & Qualifications:
Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related discipline (Master’s preferred).
8–15 years of relevant experience in a regulated pharmaceutical QA environment.
Minimum 5 years specifically in Analytical QA roles within cGMP settings.
Strong understanding of analytical instrumentation: HPLC, UV Vis, GC, pH meters, stability chambers, etc.
Familiarity with USP monographs, FDA regulations, ICH guidelines.
Excellent documentation, communication, and investigation skills.
Hands-on experience with lab software, audit trails, and equipment calibration.
Exposure to dosage forms like MDI, solids, liquids, tablets, or capsules preferred.
Proficient in MS Office and quality management tools.
Must be fluent in English – verbal and written.
Additional Information:
On-site work only (remote not available).
Relocation assistance negotiable.
Weekend or holiday shifts may occasionally be required.
Compliance with PPE and cGMP environment standards mandatory.
Must Have:
Pharma industry experience (Bio-Pharma not acceptable)
Chemistry or relevant scientific background
QA experience in manufacturing & cGMP labs
Strong command of English