The QC Sample Coordinator Associate II performs incoming and outgoing sample management for in process, release and stability studies. This role is also responsible for reference standard inventory and reconciliation to support all laboratory testing. Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements. Ensure samples are delivered in line with organizational standards, protocol specific requirements and client expectations.
- Operate to the highest ethical and moral standards.
- Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
- Coordinate and perform workflow for laboratory operations support of multiple cGMP laboratories.
- Timely and accurate cGMP compliant processing of incoming and outgoing samples and reference materials.
- Accessions samples into LIMS Sample Management and initiates sample chain-of-custody.
- Ensures all team members are trained and able to successfully complete all responsibilities for on-time availability of samples and reference standard material in accordance with Sample Management SOPs and other associated SOPs.
- Recognize and assist with the implementation of process improvement initiatives.
- Ensures data integrity and traceability.
- Generates and maintains records in a regulatory compliant manner.
- Contributes to oversight of Sample Management laboratory, including storage units and other equipment, under supervision of senior management.
- Ability to independently follow standard protocols, performs associated tasks without errors per applicable SOPs.
- Assist in distribution of all samples destined for various QC laboratories. This includes scheduling and performing timepoint pulls for stability.
- Support LIMS builds for stability studies.
- Support minor SOP writing and revisions.
- May perform sample aliquoting in a Biosafety cabinet using aseptic techniques.
- Support inventory control of all retain, reference and reserve samples, including stability samples.
- Support for timely and effective investigation of area deviations or corrective actions.
- Interact with other functional areas and/or vendors to resolve problems, enhance processes and service delivery.
- Work through Protocol questions, issues, escalations and changes with relevant project team members.
- Coordinate information and communications for designated projects at the site level, including identification and escalation of discrepancies as needed.
- Good team member skills; must work well with others.
- Excellent written and oral communication skills.
- Ability to initiate and manage day-to-day tasks effectively.
- Excellent organizational skills and attention to detail.
- Highly self-motivated.
- May lead tours of sample management area if requested.
- Maintain laboratory 5S organization, perform additional duties as needed.
- Bachelor’s degree in Scientific discipline or associate’s degree and 2+ years of industry experience or equivalent.
- 1+ years of directly related laboratory experience OR equivalent.
- Understanding of ICH Guidelines as they pertain to Stability Studies and programs
- Sample collection/distribution/testing/shipment. Performing Stability timepoint pulls
- Knowledge of GMPs, safety regulations and data integrity preferred.
- Proficiency in use of LIMS systems.
- Material receipt and inventory control.
- Ability to utilize email, word processing and spreadsheet software.
- Ability to compute basic arithmetic operations: addition, subtraction, multiplication, and division.
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 30 pounds.
- Stand/walk during entire length of shift.
- Use arms, hands and fingers to handle, feel or reach.
- Ability to climb, balance, stoop, kneel, crouch, or crawl.
- Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.