Specialist, Quality Control
200 Tech Square Cambridge, MA 02142 US
We are seeking a Quality Control Chemistry Specialist with strong chromatographic (LC/GC) experiences and troubleshooting skills. Individual in this roll is highly independent and self-motivated. He/She must have demonstrated solid scientific and technical breadth to support analytical test methods used in a biopharmaceutical manufacturing facility. The person in this role will assist lab management in OOS/OOT/OOE/LE investigation, troubleshooting methodologies, providing corrective actions and preventive actions (CAPAs), and SME training for the department. This role is assigned to the 3rd shift from Wednesday to Saturday (4 x 10 hrs., 10 pm to 8 am).
Here's What You'll Do
- Perform QC analytical chemistry testing including, but not limited to HPLC, UPLC, GC, UV, CE, Particle Count analysis, and Dynamic Light Scattering, KF, Osmolality, Digestion, etc,
- Ensure the analytical testing and laboratory documentation meet cGMP and GDP requirements.
- Perform raw material, in-process (STAT), finished product and stability sample analysis when needed.
- Support method validation/transfers and special projects as assigned
- Ensure stability testing completed within the required timeline.
- Perform troubleshooting methods and equipment
- Actively support OOS, OOT, OOE, QE and LE investigations and be able to write investigation reports.
- Participates quality event investigations such as deviations, change controls, CAPAs, effectiveness check issue the related documents and follow through the event closure as needed.
- Performs data trending and supports analysis as necessary
- Serve SME, conduct trainings and provide coaching to help developing the junior chemists
- Assist in preparation for regulatory, customer and internal quality audits
- Assist management to identify method gap, area for improvement and work on continuous improvement projects.
- Performs general laboratory support activities including reagent preparation, sample management
- Write/revise SOPs, protocols and reports if applicable
- Emphasize safety in Chemistry laboratory, identify safety risk and provide the risk mitigation actions.
- Additional duties as may be assigned from time to time
Here's What You'll Need:
- Minimum education required: Bachelors degree in a relevant scientific discipline, preferred in Analytical Chemistry, or Chemistry
- Minimum experience required: 5 years in a laboratory setting with focus in analytical chemistry
- Strong mathematical skills, including the ability to analyze scientific and test data, and solid understanding of statistical analysis
- Have in-depth knowledge of Analytical Chemistry theory (especially chromatographic separations by HPLC) and the operation of analytical laboratory equipment
- Have in-depth knowledge of analytical chemistry related to the SOPs and testing methods, especially for chromatographic separations using UPLC/HPLC/GC and the operation of general analytical laboratory equipment
- Be able to provide appropriate training of proper technical training to lab analysts.
- In-depth knowledge and expertise in method transfers/qualifications/validations
- Solid knowledge on cGMP, USP/EP/JP compendia testing requirements
- Strong communication skills as well as organizational skills
- Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment while maintaining good quality
- Details and results oriented
- Solid technical writing and data interpretation skills.
- Outstanding ability to multi-task
- Strong sense of urgency
- Ability working under pressure while maintain high quality
- Ownership to the projects and commitment to meet the timelines
- Solid knowledge of lab safety
- Highly proficient use of Microsoft Word and Excel, Chromatographic Software
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.