Senior Specialist Quality Assurance

Spectraforce

Ambler, Pennsylvania


23 days ago

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Job Description

Senior Specialist Quality Assurance 
Lower Gwynedd Township, PA 19002
6 months


Comments/Special Instructions
MUST HAVE

1) Background in Science.
2) Good Leadership and communication skills.
3) Good analytical skills.

Qualifications:
  • Looking for a Quality Assurance/Complaint Handling Unit Specialist. 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 Organon 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.

Responsibilities:
  • 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.
 

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $28.00/hr.