Digital Prospectors QC Associate II in Lexington, Massachusetts
QC Associate II
Job Type: Contract
Recruiter: Kyle Boyce (https://digitalprospectors.com/our-team/kyle-boyce)
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Job Title: QC Associate II
Location : Lexington, MA
Duration: 6-12 Months
POST-OFFER BACKGROUND CHECK IS REQUIRED. An essential function of this job is physical attendance. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
The QC Assoc II will be demonstrating expert understanding of executing QC test methods, and generates associated data packages and audits data generated by others and troubleshoots instrumentation. The Associate identifies, alerts and proposes solutions to problems on instruments and/or test executions; aiding and implementing recommended solutions and/or CAPA of OOT/OOS findings in adherence with cGMP standards. The Associate troubleshoots and repairs analytical instrumentation including HPLCs/UPLCs. We seek candidates with high-level Chromatography skills with Empower. Familiarity with cGMP’s and their application to QC is required. Candidates must be detail-oriented and safety conscious. Data must be summarized and critically analyzed for trending and reporting. Workflows must be organized independently to accomplish objectives, providing guidance and support to colleagues as required, promoting new policies and programs tactfully.
In this role, you'll be planning and supporting execution of internal and outsourced analytical testing/qualifications/stability studies of exosomes, biological molecules, oligonucleotides, small molecules, and drug products. You'll be developing QC strategy within the company and supporting external Quality consultants as required. You'll be assisting in building and maintaining good working relationships with technical counterparts at CROs, CDMOs, and within the company.
Your primary responsibilities include carrying out QC test methods for Wes, qPCR, HCP, DLS, NTA, HPLC and Residual Benzonase. You'll also be reviewing GMP product characterization, release and stability data. A highly technical background in cell/molecular bio is required. Routine Quality Control testing will also be performed in the lab.
Performing routine and stability testing in the lab
Authoring and reviewing phase-appropriate test method standard operating procedures
Reviewing release, stability and characterization data, such as technical review of change control documentation and reports, deviations, and OOS
Assisting in outsourcing of release and stability test methods, including test method transfer, qualifying assays and troubleshooting
Supporting all analytical activities to CROs and CMOs for the production of payloads (such as oligonucleotides and small molecules), exosomes, and drug product
Collaborating with Analytical Development, identifies, develops and qualifies test methods supporting phase-appropriate product release and stability testing
Generating complete, accurate, and concise lab documentation
Consistently complies with safety guidelines, cGMPs and other applicable regulatory requirements
Bachelor's or Master's degree in biochemistry, cell biology and/or molecular biology discipline
2+ years' experience in a GMP environment
Experience in analytical method development, analytical support of manufacturing campaigns, QC and method transfer
Experience in methodologies supporting biologics and small molecules
Hands-on experience authoring and reviewing of SOPs
Good knowledge of cGMP/ICH/FDA/EU regulations
Working with little supervision, demonstrates ability to troubleshoot, quickly design and execute well thought-out experiments which leads to innovative solutions
Good work ethic, striving to learn new things, with capability of working both independently and in a team environment
Strong communication, project management, and presentation skills (verbal and written)
Demonstrated experience being personable, energetic, responsive, empowering, inclusive, action-oriented, accountable, and an effective communicator.
Make this your next career move as one of our many long-term contractors or employees!
Work as our full-time employee with full benefits (Medical, Dental, Vision, STD, LTD, PTO, Retirement, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.
ABOUT DIGITAL PROSPECTORS:
Founded in 1999, Digital Prospectors is an award-winning recruiting and consulting firm that specializes in placing contract, contract-to-hire and direct hire engineers into rewarding opportunities with our impressive and ever-growing client base. We believe that all people should love their jobs.
Come see why Digital Prospectors has been voted “ Best Staffing Firm to Temp For ” by Staffing Industry Analysts, " Best of Staffing " for candidate satisfaction by Inavero / CareerBuilder.com, " Top Temporary Placement Firm " by Boston Business Journal, " Best Company To Work For " by Business NH magazine, " Excellence in IT and Engineering Staffing ” by TechServe Alliance, " Top IT Services Company " by Inc. Magazine, " Most Reliable Staffing Agency " in Forbes Magazine and " Top Ranked Staffing Firm " by Staffing Industry Analysts.
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