Senior Quality Control Analyst
Location: Bedford, MA
The Senior Quality Control Analyst is primarily responsible for development, validation, and transfer of methods for new raw materials, intermediates, and finished products as well as 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. The position will also assist in optimization of existing analytical methods.
Strategic Focus Areas:
- Perform all activities within the confines of the Quality System and cGMP principles
- Participate in projects and activities which support the growth efforts of the Company
- Maintain cost discipline within assigned programs
Specific Tactical Responsibilities:
- Coordinate with Tech Transfer during the scale up process to ensure testing methods are transferred and implemented in compliance with requirements of ICH Q2B and other applicable method validation guidelines.
- Validation of all new methods and method improvements in compliance with requirements of ICH Q2B and other applicable method validation guidelines.
- Collaborates with R&D to develop test methods for new products
- Performance of QC method qualification, validation and transfers as applicable.
- Writes technical reports to support regulatory submissions pertaining to method development, method validation, analytical testing results and product stability.
- Perform QC analytical chemistry assays using HPLC, GC, Headspace, Moisture analyzer, Karl Fisher, UV/VIS, FTIR, and Osmometric equipment.
- Test in process, stability and Engineering/R&D samples using the above listed analytical and physiochemical test methods.
- Complete required documentation for all work activities according to Good Documentation Practices; reviews lab notebooks and verifies results of other Analysts.
- Researches and optimizes test methods according to accepted industry best practice; performs qualification and validation of methods
- Reports procedural deviations and nonconformances to management; preforms investigations as assigned and follows through to closure of corrective action
- Maintains 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
- Participate in other projects as assigned
The position works on problems of complex scope in which analysis of situation or data requires review of variable factors. The Analyst exercises judgment within defined practices and procedures to determine appropriate action. The position must be able to manage multiple priorities and projects
- Requires BS in Chemistry or other Physical Science or 7-10 years of relevant experience.
- Minimum of five (5) years in a laboratory developing, validating, and performing analytical methods.
- 5+ years testing experience in FDA regulated pharmaceuticals or medical device industries
- Demonstrated experience with GMP/ ISO regulations
- Proficient in HPLC, GC analyses, FTIR, and UV/Vis. Demonstrated experience with complex manual and automated test methods and equipment.
- 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
Desired Experience, Knowledge, and Skills:
- Experience with testing textiles, gels, solids, and liquid suspensions
- Experience working in a high volume commercial plant
- Ability to handle multiple priorities and meet established deadlines
- Experience maintaining working with Excel performing calculations and graphing operations
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.