The Associate II will contribute to building and maintaining the Quality Control (QC) GMP infrastructure for Abzena. This role is responsible for providing technical support for the QC testing laboratories. This personnel is responsible for ensuring analytical equipment qualification, computer software validation, and method transfer activities have been completed. They will also facilitate out of specification/anomalous results investigations, major deviations, and other quality systems. They will be involved with stability and reference standard protocols and reports. They may lead process improvements within QC. The QC Associate II may train and mentor QC Associates responsible for testing.
- Support QC laboratory analysts with quality systems management (training, change control, deviations, method transfer, etc.)
- Conduct OOS, OOT, and non-conformance investigations, perform risk assessments, gap analysis, investigation, and review of deviations, and implementation of CAPAs and root cause investigations and/or assist management of these investigations
- Author, review and revise Standard Operating Procedures (SOPs), technical documents, protocols, and reports
- Assist facility managers ensuring timely calibration of equipment
- Review and approve the qualification of equipment performed by qualified vendors or perform, as needed
- Complete qualification, transfer, validation, and verification of analytical methods
- Document work in forms and logbooks according to organizational GDP policies
- Provide maintenance, cleaning, calibration, troubleshooting, and repair of analytical instruments and equipment
- Manage work carried out by third-party and metrology service providers
- Work with other teams to determine analytical methods and instruments needed to support GMP manufacturing
- Adhere to EHS and quality standards set by regulations
- Adhere to company’s quality standards, regulations, policies and procedures
- Operate to the highest ethical and moral standards
- Participate effectively as a team player in all aspects of Abzena’s business
- Communicate effectively with supervisors, support staff, colleagues, clients, vendors, etc.
- Attend, contribute to, and lead relevant meetings
- Prioritize, plan, and manage work schedule effectively and efficiently
- Keep up to date with EHS, cGMP, scientific, and technical developments
- Evaluate lab practices for continuous improvement
- A BS degree in a relevant discipline (e.g., chemistry, biological sciences, bioengineering, etc.)
- Practical knowledge in all aspects of product development from investigational phase to commercial
- Experience in the establishment and operation of QC laboratories in a GMP regulated environment
- Strong technical writing skills
- 2-4 years experience working in a GMP laboratory environment QC Management experience a plus
- Experience in 21 CFR Parts 210 and 211 and other applicable FDA/ICH guidance documents
- Working knowledge of U/HPLC, GC, Karl Fisher, UV-Vis, FTIR, SDS-PAGE, ELISA, CE, and compendial assays
- Ability to multitask and work well under pressure
- The ability and knowledge to evaluate data trending and control chart interpretation
Travel between Abzena sites (Bristol PA, San Diego CA and Sanford NC) as needed.
- Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
- Frequently lift and or move objects up to 20 pounds.
- Stand/walk during entire length of shift.
- Use arms, hands and fingers to handle, feel or reach.
- Ability to wear the required personal protective equipment such as safety glasses, gloves, laboratory coat, dust/chemical inhalation protection, ear protection.
- Ability to climb stairs/approved step ladders, balance, stoop, kneel, crouch, or crawl.
- Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.