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QA Associate-Validation

Aesculap Biologics
Requisition ID 2018-13183
Company Aesculap Biologics
# of Openings 1
Job Locations US-PA-Breinigsville
Category Quality
Position Type Regular Full-Time
Shift 8 a.m. to 5 p.m.
Site Aesculap
Overview
Aesculap Biologics, LLC, was established in January 2012 as a division of Aesculap, Inc. and is focused on biological approaches to the repair and regeneration of diseased or damaged tissues. Using a combination of cells, growth factors and smart biomaterial devices, Aesculap Biologics products can stimulate and support the synthesis of new tissue and enhance the body's own regenerative power to improve the quality of patient's lives.
Responsibilities
Position Summary:
The QA Associate (Validation) will be responsible for developing and executing a variety of validation and FDA compliance related documents/protocols for equipment, systems, and processes in support of Cell therapy manufacturing operations to assure compliance with cGMPs and Good Tissue Practices. This position will work with stakeholders to maintain the GMP status of equipment, systems, and processes. This position is responsible for project management to set and meet lead times to ensure validation, periodic assessment and requalification projects stay on schedule. This position is responsible for product safety and quality and has a direct impact on patient safety. All job functions must be carried out responsibly, competently and conscientiously to ensure that Aesculap Biologics' products are safe and effective.
Responsibilities: Essential Duties

  • Interprets and understands relevant laws and standards and provides guidance to Operations, Development and Quality staff to provide instruction, advice, and enforcement of GMP/GTP compliance.
  • Reviews, and approves SOPs, validations, and other documents and records for accuracy, consistency and compliance with relevant federal and state regulations.
  • Develops/Authors technical documents including Quality system records, SOPs, work instructions, validations (URS, DDS, IOQ, PQ, UAT, Reports), investigations, etc. in compliance to applicable laws and standards.
  • Executes and manages periodic assessment and requalification's for controlled temperature units (CTUs), lab instruments, computerized systems, processes, and facilities.
  • Conducts thermal validation testing using thermocouple sensors and data collection instruments (Kaye Valprobe, AVS) on equipment including GMP controlled temperature units (CTUs).
  • Executes and manages risk assessment, planning, and execution/mitigation activities to ensure the quality of equipment, systems, processes used in the manufacture of product are maintained throughout their lifecycles.
  • Manages suppliers/contractors contracted to perform GxP functions (installation, commissioning, validation), as required.
  • Manages the Site Validation Master Plan.
  • Performs technical reviews and interprets data for accuracy of equipment/process performance for completed validations/revalidations
  • Conducts system administration activities for computerized systems (e.g. user management, periodic maintenance, updates, etc.), as required.
  • Maintains metrics for periodic assessment/requalification activities.
  • Participates in cross-functional design, development, improvement and investigative activities (root cause analysis). Capable of applying and leading teams in the use of Quality Tools, such as FMEA, in design, development, improvement and investigative activities.

Expertise: Knowledge & Skills

  • This position may be exposed to potentially contaminated instruments and blood or other bodily fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, AB will provide a safe working environment for all employees.
  • The ability to gown and mask for performance or observation of aseptic processing in a clean room environment is required.
  • Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors.
  • Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
  • Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Qualifications
Expertise: Qualifications - Experience/Training/Education/Etc
Required:

  • BS/BA degree in the life sciences, engineering, or related field is required.
  • 0-3 years of Quality System / GMP experience in Pharmaceutical, Biotech or Medical Device industry is desirable.
  • The ability to process, analyze, and present data for the effective presentation of concepts and ideas. Some knowledge of basic statistical analysis is required.
  • Must have ability to exercise judgement and prioritize and execute the appropriate course of action(s) as dictated by the complexity of the scenario.
  • Must be adaptable, customer service oriented, have a positive attitude.
  • Must be detail oriented and have strong organizational skills.
  • Must be able to work independently and effectively as part of a team, exhibiting effective interpersonal skills.
  • Strong Computer skills in spreadsheet and word processing applications is required.
  • Excellent technical oral and written communication skills are required.

Desired:

  • Working knowledge and experience with process improvement and analysis tools (e.g. Pareto analysis, control charts, Root Cause analysis, FMEA, etc.) is a plus.
  • The ability to interpret the cGMPs/GTPs, federal and state regulatory requirements is a plus.
  • Experience with Document Management, Training Management, Maintenance Management and ERP systems is a plus.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position could require the handling of instruments that may or may not have been contaminated by blood or other body fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide a safe working environment for all employees.
The noise level in the work environment is usually moderate.
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PI105301582



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