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Contact Name: DAVE

Job Details: Quality Assurance Specialist Date: Jun 28 2021

Job Reference: 3262
Job Category: IT Jobs [ View All IT Jobs Jobs ]
Company Type Recruiter
Employment type: Full Time, Contract
Degree: High School
Experience: 3 years
Location: Lewes, Delaware, 19958
Job Skills: Quality Assurance Specialist
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Job Description

Perform deviation investigations that occur and manage the investigations to closure. Be proficient in material disposition/justification and CAPA effectiveness review. Ensure product / material under investigation is quarantined as needed and segregated accordingly.
Perform customer complaint investigations and prepare responses.
Understand the role and importance of change control at the site and ensure that the process is executed as written.
Perform more complex projects/studies/reviews independently as assigned.
Mentor/train junior Quality staff in areas of expertise.
Interpret investigative data/results independently and draw conclusions.
Contribute substantially to the overall performance of the Quality Unit at the site.
Liaison with toll or contact manufacturers where applicable.
Bachelor degree in a Science is required
6-10 years of equivalent work experience within the pharmaceutical industry.
Experienced with Quality Unit activities such as GMP documentation review/approval, investigation management, auditing, product and raw material release, change control, complaint resolution and training
Change management. The ability to accept, support and implement new ideas and procedures and the site.
Problem analysis and problem resolution.
Excellent interpersonal and communication skills.
Experience with Microsoft Office products required. Experience with ERP and LIMS desirable.
Previous management and/or supervisory capability with strong decision making skills needed.

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