Quality Assurance Specialist

Job Description:

• Responsible for executing relevant procedures to ensure Product Quality Complaint (PQC) and Adverse Event Quality Investigation (AE-QIR) intake management processes comply with regulatory expectations.

• Responsible for receipt, processing, and follow-up of Product Quality Complaints or Adverse Event Quality Investigation Requests.

• Acts as an effective liaison between Organon support functions worldwide for complaint-handling activities to maintain regulatory compliance.

• Provides expertise in complaint-handling processes and systems to resolve issues and drive continuous improvement.

• Manages the intake of complaint samples for the US market. Identifies appropriate investigating sites, documents sample information, prepares the sample for shipment to the investigating site when designated by LCIU, performs functional testing, and documents all findings in the complaint records.

Qualifications:
HYBRID ROLE - the role requires physical management of complaint samples in our BSL-2 lab, located in Spring House, Pennsylvania.
Be able to open the sample to do a visual inspection and triage and classify them accordingly.
Be able to process and inspect various Client Products like inhalers, syringes, vials, etc.
Have good communication skills to hold productive conversations with multiple cross-functional teams.
Have leadership skills and be able to think critically and analytically.
Have experience with MS Office/Teams.
Good to have experience with software like QCC4 and SAP.

MUST HAVE
1) Background in Science.
2) Good Leadership and communication skills.
3) Good analytical skills. During the contract's start, the person WILL BE ON SITE EVERY DAY, this could be at least a month but is subject to change and the contractor should be comfortable coming to the office beyond that as well if need be. Eventually, it will move to 3 days a week on site but this should not be expected to happen immediately. There should be flexibility in coming to the office as and when required. This is a 6-month contract, with no guarantee of extension or going perm.

The exact address for the role is Spring House Innovation Park, 727 Norristown Rd, Lower Gwynedd Township, PA 19002

Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.