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Senior Specialist Quality Assurance
Ambler, PA
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:
Responsibilities:
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 nahr@spectraforce.com if you require reasonable accommodation.
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.
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 nahr@spectraforce.com if you require reasonable accommodation.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
Open
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