Role Summary:
Responsibilities:
1) Receive, clean, and evaluate product complaint return samples
2) Interface with various Client sites and business partners
3) Manage complaint return sample inventory
4) Author technical assessment reports
Requirements: Bachelor's Degree in Life Sciences or related field or the equivalent combination of education and/or experience. Typically, 2 plus years of related quality assurance or manufacturing experience in a GMP pharmaceutical or medical device industry. Evaluate documentation and operation according to company guidelines. Be self-motivated, attentive to details and able to prioritize and meet deadlines. Basic statistical mathematical skills including the ability to trend data. Basic project management skills. Independently understand, follow, and implement instructions. Written and verbal communication & collaboration skills. Strong word processing, database, and spreadsheet application skills. Strong organizational skills with the ability to manage multiple projects or assignments. Role may involve periods of prolonged sitting and standing. Role may involve lifting boxes and storage containers of up to 50lbs. Role may involve transporting samples to different buildings across campus.
Basic Qualifications
High school/GED + 4 years’ work experience or Associate + 2 years’ work experience or Bachelor + 6 months’ work experience or Master’s Degree
Top 3 Must Have Skill Sets:
Attention to Detail
Organizational skills
Communication skills
GDP/GMP is a plus
Day to Day Responsibilities:
Receive, open, and verify returned samples from patients and healthcare providers. Photograph and perform X-ray evaluations of the returned samples. Document a written inspection of the returned unit to submit in the GMP Bio Connect System. File completed samples in storage. Clean and prepare Bio mailers for the mail centre to ship to patients/HCP. Transfer units to the warehouse for shipment to other sites.
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