Connexion Systems + Engineering
https://www.csetalent.com/wp-content/uploads/2021/04/connexion-social-logo.png
http://www.csetalent.com
http://www.csetalent.com
true
Emily Donahue
Specialist, Quality Control
Walpole , MA 02062 US
Posted: 03/28/2023
2023-03-28
2023-07-02
Industry: Scientific and Life Sciences
Job Number: 15479
Job Description
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.
Title: Specialist, Quality Control
Hiring Organization: Connexion Systems & Engineering
The Role
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
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
When responding to this job posting you MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to . We would be glad to help you find the perfect job!
Â
Title: Specialist, Quality Control
Hiring Organization: Connexion Systems & Engineering
- Duration: Temp- Perm
- Pay rate: $ 18.00-$29.00/hr
- Job Location: Walpole, MA
- Job# 15479
The Role
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 neded.
- 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
- Minimum education required: bachelor’s 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.
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
When responding to this job posting you MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to . We would be glad to help you find the perfect job!
Â
Meet Your Recruiter
Emily Donahue
Regional Recruiting Manager
- Directs the recruitment efforts for both the Quincy, MA and Providence, RI branches.
- Manages a distributed team of recruiting leads, individual contributor recruiters and account managers.
- Responsible for leading the fulfillment and execution of sourcing, recruiting, sales and business development practices across the region.
