Quality Control Chemist Iii

3 weeks ago


Bedford, United States Actalent Full time

'''Job Summary'''

**Great opportunity to get your foot in the door with one of the top Biotech companies in the Bedford, MA area**

**Must have experience with HPLC, GC/GCMS, Karl Fisher and wet chemistry techniques**

**Description**:
Quality Control Analyst II is primarily responsible for the activities and procedures which are required to sample and test raw materials, work-in-process samples, finished goods, and stability samples under cGMP conditions. The position follows established procedures in the execution of daily activities and completes required documentation.
- Testing of incoming raw material according to USP, EP, or ACS Reagent Index
- Performance of QC analytical chemistry assays, HPLC, GC & GC/MS, Headspace, Moisture analyzer, Karl Fisher as well as wet chemistry assays.
- Testing of in process and release manufacturing samples, stability samples and Engineering/R&D samples using the following instrumentation/techniques:

- HPLC
- GC & GC/MS
- UV/Vis Spectrophotometry
- FTIR Spectrophotometry
- Auto & Manual Titrations
- Freezing Point & Vapor Pressure Osmometry
- Absolute Viscosity using Brookfield Cone/Plate Viscometer
- Intrinsic Viscosity using Ubbelohde Tube and Dilute Solution Viscometer
- pH Meter
- TOC Analyzer
- Conductivity Meter
- Complete required documentation for all work activities according to Good Documentation Practices; reviews lab notebooks and verifies results of other Analysts
- Collaborates with R&D to develop test methods for new products Performance of QC method qualification, validation and transfers
- Researches and optimizes Test methods according to accepted industry best practice; performs qualification and validation of methods
- Report procedural deviations and nonconformance's to management; preforms investigations as assigned and follows through to closure of corrective action
- Maintain current training on all assigned procedures to include read & understood, skills development and classroom training activities as required
- Performance of QC general laboratory equipment maintenance

**Additional Skills & Qualifications**:

- Requires BS in Chemistry or other Physical Science
- 2 - 5 years testing experience in FDA regulated pharmaceuticals or medical device industries
- Demonstrated experience with GMP/ ISO regulations
- Proficient in HPLC, GC analyses and prior experience in method development and method validation.
- Demonstrated experience with basic lab instrumentation including UV/vis and FTIR spectrophotometers, pH Meters, and Osmometers
- Skilled in various wet chemistry techniques such as titrations and compendial ID testing
- Constantly strives to exceed goals, requirements, accomplishments and expectations
- Ability to work flexible hours to complete work activities

**Job Types**: Full-time, Contract

Pay: $30.00 - $40.00 per hour

**Benefits**:

- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance

Schedule:

- 8 hour shift

Ability to Relocate:

- Bedford, MA: Relocate before starting work (required)

Work Location: In person


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