Associate II, Quality Assurance

Full Time
Bristol, PA 19007
Posted
Job description

The Associate II, QA - Product Disposition will be responsible for ensuring the site performs in a state of compliance by leading and supporting all Quality oversight activities related to product disposition of Drug Substance, Intermediates, Drug Product, meeting all applicable regulatory requirements and Abzena standards. This will be accomplished by fostering an empowered culture of quality across all functions. The Senior Quality Assurance Associate-Product Disposition will additionally provide Quality Systems support, as required.

Responsibilities

  • The Associate II, QA Associate Product Disposition is a regular Business Hours role that will support the Product Disposition quality function.
  • Works closely with colleagues through all phases of drug process to ensure compliance and timeliness of GMP work.
  • Manages and oversees the disposition process of DS/DP/Intermediates.
  • Organizes activities to ensure timely disposition of DP/DS/Intermediates.
  • Maintains consistent communication with programs/project managers to understand customer needs and timelines.
  • Participates in client and regulatory inspections.
  • Identifies and executes efficiency projects for the area.
  • Authors/reviews SOPs, deviations, CAPAs, and change controls.
  • Performs final disposition of finished product for clinical/commercial use, ensuring country-specific disposition requirements are met.
  • Assists with executing and maintaining Electronic Management Systems as it relates to product disposition, i.e., ERP.
  • Participates effectively as a team player in all aspects of Abzena’s business.
  • Exhibits professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
  • Provides communication in both verbal and written formats.
  • Prioritizes and manages workload for multiple projects and tasks simultaneously to successfully meet goals and objectives.
  • Operates in both a team and individual setting with minimal supervision.
  • Makes decisions pertinent to their area of responsibility.
  • Exercises higher level judgment and assessment skills for more than 75% of the assigned workload.
  • Adheres to quality standards set by regulations and Abzena policies, procedures, and mission.
  • Operates to the highest ethical and moral standards.
  • Complies with Abzena's policies and procedures.
  • Communicates effectively with clients, supervisors, colleagues, and staff.
  • Participate effectively as a team player in all aspects of Abzena’s business.
  • Perform other duties as assigned.

Requirements:

  • Minimum of B.S. degree in Life Sciences or related discipline with ≥ 3 years of experience in a GMP regulated Biopharmaceutical facility or equivalent.
  • Relevant experience in product quality activities similar or related to product disposition, shop floor QA, incoming quality.
  • Knowledge of industry standards and regulation requirements for biologics and parenteral products in clinical development and commercial.
  • Knowledge of GMP regulations (US, EU and ROW), good documentation practices, cGMP, 21CFR, USP and other applicable regulations, standards, and guidance.
  • Proven ability to complete all work with detailed accuracy.
  • Proven ability to work in a fast-paced environment to meet tight deadlines.
  • Proven ability to serve as an active participant and contributor in cross-functional meetings.
  • A proven ability to analyze, assess, and resolve issues as they arise.

Travel between Abzena sites (Bristol PA, San Diego CA and Sanford NC) as needed.

Physical Requirements:

  • 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.
  • Visual abilities including near and far sight, color, peripheral vision, depth, and ability to focus.
  • Ability to gown and gain access to cleanroom and utility areas.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.

Responsibilities

  • 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.

Requirements:

  • 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.

Physical Requirements:

  • 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.

Job Type: Full-time

Pay: $1.00 - $10.00 per year

Benefits:

  • 401(k)
  • Dental insurance
  • Health insurance
  • Paid time off
  • Vision insurance

Schedule:

  • Monday to Friday

Ability to commute/relocate:

  • Bristol, PA 19007: Reliably commute or planning to relocate before starting work (Required)

Experience:

  • Manufacturing (Preferred)

Shift availability:

  • Day Shift (Preferred)

Work Location: In person

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