The Quality Control Lead Analyst (within the analytical group) is responsible for leading the QC analytical team to ensure analytical testing of new methods, in-process and release testing is completed to support the site manufacturing.
Duties and Responsibilities
Supervision of the QC Analytical group, including day to day activities, data review, laboratory investigations and troubleshooting.
In accordance with test method SOP's perform site testing on in-process and release samples from manufacturing and stability
Interface with site wide groups to schedule activities within the QC lab to meet the needs of the site
Always maintain sample and data integrity
Use sophisticated laboratory instrumentation and computer systems to collect and record data.
Participate in the investigation of deviations, OOS/OOT, abhorrent results.
Maintain inventory/supplies necessary to conduct routine testing.
Lead continuous improvement practices (QLP, 5S, LEAN, etc.)
Perform equipment maintenance and calibrations as required.
Ensure department readiness for audits by both internal and external authorities. Serve as the Quality Management backup person for the lab, and interface with investigators during both internal and external inspections.
Perform and/or supervise validation of analytical methods per ICH USP guidelines, experience authoring SOP's, investigations, deviations and change controls.
Lead new analytical method establishment
Assist in method development and troubleshoot instruments
B.S. in Chemistry or related scientific discipline (Or master's degree)
8+ years of Quality Control experience in a cGMP biologics environment or master's degree and 4-6 years of related experience
Knowledge of most laboratory equipment including but not limited to HPLC, UV, Elisa, CE, iCE
Understanding of GMP's with expectations of a commercial GMP environment
Must communicate effectively (verbal and written) with director and peers. Written
communicate skills require full competence in following detailed written instructions,
creating/revising SOP's and reports
Advanced knowledge of basic chemical and biological safety procedures/precautions
Proficient in Microsoft Office - Outlook, Word, Excel, PowerPoint quired pursuant to state or federal regulatory requirements
Why Work here?
-Prime location outside of Cambridge but paying Cambridge $$$
-Diversity of projects- working for CDMO will give candidates a varied workload
-Site has numerous expansion plans over the next 3-5 years
- 401k match
- bonus program
- Referral program
- Recognition program
- health - dental - vision
- Life insurance
- HSA options
- 120 hours of vacation accrued in first year
- 64 hours of sick time immediately (prorated to when they start the year)
- tuition reimbursement
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing ® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call or email .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.