Quality Control Analyst II
Anika
9 hours ago
On-site
Bedford, MA
$82,000 - $92,000 USD yearly
Operations
What You’ll Do
- Perform analytical chemistry testing and laboratory activities supporting raw materials, in-process samples, finished goods, and stability programs under cGMP conditions.
- Ensure product quality, regulatory compliance, and timely release of materials.
- Develop subject matter expertise in analytical testing methodologies, laboratory instrumentation, and quality control systems.
How You’ll Contribute
- Perform analytical testing of incoming raw materials (USP/EP/ACS Reagent Index and approved internal methods).
- Execute analytical chemistry assays for in-process, release, stability, Engineering, and R&D samples (chromatographic, spectroscopic, and wet chemistry techniques).
- Operate/maintain laboratory instrumentation (HPLC, GC, GC/MS, UV/Vis, FTIR, pH meters, osmometers, TOC analyzers, conductivity meters, viscometers, titration systems).
- Perform Karl Fischer, headspace, auto/manual titrations, viscosity testing, and compendial identification testing.
- Complete GDP/cGMP-compliant documentation; review results and support data integrity.
- Collaborate on method development/transfer/qualification/validation.
- Report deviations/nonconformances; support investigations and corrective actions.
- Maintain training compliance; perform routine equipment maintenance; support continuous improvement.
What You Bring (Required)
- Bachelor’s degree in Chemistry/Physical Science (or related); equivalent experience considered.
- 2–5 years analytical testing in FDA-regulated pharma or medical device industries.
- Knowledge of GMP and ISO regulatory requirements.
- Hands-on HPLC and GC (method development/validation).
- Instrumentation experience (UV/Vis, FTIR, pH meters, osmometers).
- Wet chemistry skills (titrations; compendial identification).
- Strong documentation, organization, problem-solving; manage multiple priorities.
- Flexibility to support varying work schedules.
Nice to Have
- GC/MS, TOC analyzers, conductivity meters, viscometers.
- Analytical method transfers/qualification; stability testing/trending.
- Spreadsheets and basic graphs/trend reports.
Benefits (if applicable)
- Discretionary bonus; comprehensive healthcare; HSA; 401(k) with up to 5% match; employee stock purchase plan (15% discount); accrued paid time off; long-term incentives including stock awards.
- Perform analytical chemistry testing and laboratory activities supporting raw materials, in-process samples, finished goods, and stability programs under cGMP conditions.
- Ensure product quality, regulatory compliance, and timely release of materials.
- Develop subject matter expertise in analytical testing methodologies, laboratory instrumentation, and quality control systems.
How You’ll Contribute
- Perform analytical testing of incoming raw materials (USP/EP/ACS Reagent Index and approved internal methods).
- Execute analytical chemistry assays for in-process, release, stability, Engineering, and R&D samples (chromatographic, spectroscopic, and wet chemistry techniques).
- Operate/maintain laboratory instrumentation (HPLC, GC, GC/MS, UV/Vis, FTIR, pH meters, osmometers, TOC analyzers, conductivity meters, viscometers, titration systems).
- Perform Karl Fischer, headspace, auto/manual titrations, viscosity testing, and compendial identification testing.
- Complete GDP/cGMP-compliant documentation; review results and support data integrity.
- Collaborate on method development/transfer/qualification/validation.
- Report deviations/nonconformances; support investigations and corrective actions.
- Maintain training compliance; perform routine equipment maintenance; support continuous improvement.
What You Bring (Required)
- Bachelor’s degree in Chemistry/Physical Science (or related); equivalent experience considered.
- 2–5 years analytical testing in FDA-regulated pharma or medical device industries.
- Knowledge of GMP and ISO regulatory requirements.
- Hands-on HPLC and GC (method development/validation).
- Instrumentation experience (UV/Vis, FTIR, pH meters, osmometers).
- Wet chemistry skills (titrations; compendial identification).
- Strong documentation, organization, problem-solving; manage multiple priorities.
- Flexibility to support varying work schedules.
Nice to Have
- GC/MS, TOC analyzers, conductivity meters, viscometers.
- Analytical method transfers/qualification; stability testing/trending.
- Spreadsheets and basic graphs/trend reports.
Benefits (if applicable)
- Discretionary bonus; comprehensive healthcare; HSA; 401(k) with up to 5% match; employee stock purchase plan (15% discount); accrued paid time off; long-term incentives including stock awards.