Address
Form of work Title : QA Specialist - Onsite
Location : Lebanon, PA 17042/Fort Washington, PA 19034 (2 locations available)
Duration : 12+ months contract
Job Description:
What will you do:
Within the Commercial Quality organization, this position is responsible for regional leadership of the Quality resources which provide Quality Operations support services in the areas of Transportation, Temperature Control, and Customer Service. The Staff Quality Specialist, Commercial Quality NA is responsible for ensuring the robustness, efficiency, effectiveness, and continuing suitability of service delivery in the NA region.
Responsibilities:
A minimum of a Bachelor's degree; a focused degree in Engineering, Life Science, Physical Science, or related subject area or equivalent years of experience is preferred
Minimum of 6 years' overall experience
Previous experience in Quality (preferably the fields of Quality Engineering or Quality Systems and Compliance within a regulated industry) in the Pharmaceutical, Medical Device, OTC Drug and/or Cosmetic production environment.
Knowledge of applicable US and international regulatory requirements for design, development, manufacture, and post market surveillance and field actions.
A solid understanding of FDA 21 CFR Part 210, 211, IS0 9001, 820 and/or ISO 13485 and ERP systems
A working knowledge of INV/CAPA, Change Control, and General Quality Systems processes.
Prior experience in Supplier Quality
Strong communication, teamwork, problem solving, decision-making, data analysis, inductive reasoning, critical thinking and root cause analysis skills.
Excellent analytical, prioritization, multi-tasking, communication, and strong leadership skills and the ability to work independently without supervision.
Prior experience preparing and presenting written and verbal reports to upper management and business unit heads pertaining to metrics and/or audit findings.
Ability to work effectively on cross functional teams.
Desired qualifications:
Experience with Quality System IT platforms (e.g. EtQ, PRISM, QLIK, QEM, tru Vault, Compliance Wire, Summit, DMS, LMS),
Experience working with virtual teams and teams across multiple locations and countries.
Strong influencing skills.
Being comfortable and effective at communicating with Leadership.
Must be able to work independently as well as on teams, with the flexibility to handle complexity and multiple initiatives.
E2E Mindset with ability to execute locally/regionally.
Location : Lebanon, PA 17042/Fort Washington, PA 19034 (2 locations available)
Duration : 12+ months contract
Job Description:
What will you do:
Within the Commercial Quality organization, this position is responsible for regional leadership of the Quality resources which provide Quality Operations support services in the areas of Transportation, Temperature Control, and Customer Service. The Staff Quality Specialist, Commercial Quality NA is responsible for ensuring the robustness, efficiency, effectiveness, and continuing suitability of service delivery in the NA region.
Responsibilities:
- This role provides leadership for certain services element for Commercial Quality to support a rapidly changing business with complex and diverse product lines. Primary services in scope include:
- Quality Operations support for the Regional Transportation Organization and the IRTE organization executing in NA
- Ensuring compliant regional execution and implementation of transportation lane mapping studies, mode qualifications, and temperature control systems related to transportation (e.g. monitoring)
- Quality Operations support the customer service organizations in the region.
- Providing Transportation and Temperature Control supplier quality management services in accordance with standard purchasing controls procedures.
- Interfacing with Regional Deliver Operations to provide a consolidated Quality Review, Metrics, and Reporting for the services in scope.
- Ensures robust performance and continuous improvement of the supplier quality program. Responsible for strategic aspects of regional supplier management. Influences and drives improvement in supplier performance through engagement at quarterly business reviews.
- Implements programs and projects to achieve cost improvement targets.
- Develop and manage relationships with internal and external trade and regulatory organizations as appropriate.
- Leads and supports activities in the areas of Audit and Inspection, Change Control, NC/CAPA, Root Cause
- Analysis, and Documentation Control.
A minimum of a Bachelor's degree; a focused degree in Engineering, Life Science, Physical Science, or related subject area or equivalent years of experience is preferred
Minimum of 6 years' overall experience
Previous experience in Quality (preferably the fields of Quality Engineering or Quality Systems and Compliance within a regulated industry) in the Pharmaceutical, Medical Device, OTC Drug and/or Cosmetic production environment.
Knowledge of applicable US and international regulatory requirements for design, development, manufacture, and post market surveillance and field actions.
A solid understanding of FDA 21 CFR Part 210, 211, IS0 9001, 820 and/or ISO 13485 and ERP systems
A working knowledge of INV/CAPA, Change Control, and General Quality Systems processes.
Prior experience in Supplier Quality
Strong communication, teamwork, problem solving, decision-making, data analysis, inductive reasoning, critical thinking and root cause analysis skills.
Excellent analytical, prioritization, multi-tasking, communication, and strong leadership skills and the ability to work independently without supervision.
Prior experience preparing and presenting written and verbal reports to upper management and business unit heads pertaining to metrics and/or audit findings.
Ability to work effectively on cross functional teams.
Desired qualifications:
Experience with Quality System IT platforms (e.g. EtQ, PRISM, QLIK, QEM, tru Vault, Compliance Wire, Summit, DMS, LMS),
Experience working with virtual teams and teams across multiple locations and countries.
Strong influencing skills.
Being comfortable and effective at communicating with Leadership.
Must be able to work independently as well as on teams, with the flexibility to handle complexity and multiple initiatives.
E2E Mindset with ability to execute locally/regionally.
