We are looking for a QC Lab Tech/Scientist who has Quality Assurance experience and COA experience. We are open on level (QAI, QAII, or Sr QA) for this role!
About Biopeptek Pharmaceuticals: Biopeptek Pharmaceuticals is a leading Contract Development and Manufacturing Organization (CDMO) specializing in peptide therapeutics. We provide end-to-end peptide services, from early development to commercialization, while adhering to the highest standards of quality and compliance. Our team of experts is dedicated to delivering cutting-edge peptide solutions that meet the unique needs of our clients.
Job Description: Biopeptek Pharmaceuticals is seeking a Quality Associate to join our Quality Control team. The incumbent will play a vital role in ensuring the accuracy and consistency of our Certificate of Analysis (COA) post analytical testing. They will be an integral part of our efforts to maintain the highest standards of quality for our peptide products.
Responsibilities:
Review and verify the COAs for accuracy and completeness after analytical testing.
Cross-check the analytical data and results against predefined quality standards and acceptance criteria.
Support internal teams in the interpretation and understanding of COA results.
Initiate non-conformance reports and corrective actions when deviations are identified.
Document and report any deviations or anomalies in the COA to the Quality Control Supervisor.
Participate in internal audits to ensure adherence to quality control procedures and protocols.
Contribute to continuous improvement initiatives aimed at enhancing quality control processes.
Comply with all regulatory guidelines and procedures relevant to pharmaceutical peptide production.
Requirements
Bachelor's degree in Chemistry, Biology, or a related scientific discipline preferred.
Minimum 1-2 years of experience in quality control or assurance in a pharmaceutical or biotech industry, preferably in a CDMO environment preferred.
Knowledge and understanding of analytical testing methods and processes.
Familiarity with industry standards and regulations such as GMP, FDA, EMA, etc.
Strong attention to detail with the ability to identify errors and inconsistencies.
Excellent written and verbal communication skills.
Ability to work in a fast-paced, team-oriented environment.
Proficient in using Microsoft Office suite (Word, Excel, PowerPoint).
Benefits
For employees:
-80% employer-paid MEDICAL HMO plan
-80% employer-paid DENTAL PPO plan
-80% employer-paid VISION plan
For dependents: we pay ~ 40% of the above
-We are in works to add 100% employer-paid Basic Life/ADamp;D + ST Disability
-IBX PPO: smaller employer % match
-4% match 401k
PTO: 15 days total (vacation/personal days) + 5 sick days + holidays
Benefits are subject to change: What we pay is subject to our decision and can change at any time and for any reason, with or without notice.