QA Compliance Specialist
Job brief
Specific Job Requirements
- Excellent technical writing skills.
- Critical thinking skills.
- Detail oriented.
- Ability to collaborate as a member of cross-functional teams.
- Support media fills.
- Evaluate and investigate reported Customer Complaints
- Inspect product inventory, associated lots and retention samples for associated product complaint.
- Review manufacturing records and non-compliance documents during complaint investigation.
- Maintain vial inspection certification.
- Complete Complaints/AE Investigation Approval.
- Assist with management of supplier qualifications.
- Assist in investigation and review of Deviations/CAPAs
- Maintain/Document RGA/RMA retention and destruction
- Assist/Respond in Internal and External Audits
- Generate complaint data for QMR Data
- Assist in Regulatory Inspections
Requirements
Work Experience Requirements
- Must be fully knowledgeable and competent as related to the role/responsibilities of Quality Operations
- Provide direct support to QA Compliance and Qaulity Operations
- Liaise with other functional areas to ensure appropriate and adequate communication to facilitate complaint investigations, supplier management, internal audits and quality investigations.
- Assist in driving Quality Operations priorities to completion.
- Ability to collaborate in cross-functional teams.
- 2-3 years of pharmaceutical industrial experience in Quality
Education Requirements
This position requires the following minimum education:
- Bachelor’s or Associate Degree in a technical field and 3+ years of pharmaceutical manufacturing/quality experience, is required.
Physical Demand(s)
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Must be able to wear the proper garb required.
- Must be able to pass visual acuity test
Computer Skill(s)
To perform this job successfully, an individual should have knowledge of basic computer knowledge such as Word Processing and Database software as well as Edwards or equivalent inventory software.
About STALLERGENES GREER International AG
Stallergenes Greer is an international biopharmaceutical company specialized in the research, diagnosis and treatment of respiratory, food and venom allergies through the development and marketing of Allergenic Immunotherapy treatments.
Our mission is to offer the full potential of precision medicine to improve the quality of life of people suffering from allergies.
Allergenic Immunotherapy (AIT) is the only treatment for respiratory allergic diseases that allows for a lasting re-education of the patient’s immune system by inducing an increasing tolerance to allergens.
With more than 1,100 employees worldwide, and production sites in Europe and the United States, Stallergenes Greer offers its medicines in 44 countries.
Would you like to participate in the development of a world expert group in its field, in a dynamic and multicultural environment?
Join our Stallergenes Greer teams!
- Job category : Quality Assurance
- Job type : Full time
- Contract type : Permanent contract (CDI)
- Job location : United States
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