- Managing receipt, processing, and monitoring of customer complaints
- Reviewing laboratory data and releasing finished products
- Serving as the main QA contact for customers regarding quality concerns
- Engaging with various teams for customers and providing necessary approvals
- Overseeing GMP-related documents and providing feedback as needed
- Providing Quality Assurance consultation on complaints, deviations, change controls, and procedures
- Ensuring investigations are conducted and closed within set timeframes
- Reviewing and releasing commercial batches according to schedules
- Leading and completing complaint investigations
- Ensuring standard operating procedures and processes are efficient and meet industry requirements
- Providing support during inspections and audits
- Bachelor's Degree in Chemistry, Biology, Pharmacy, or related field
- 2-5 years' experience in FDA regulated environment, preferably in pharmaceutical manufacturing
- QA/compliance experience in manufacturing, laboratory compliance, and quality systems
- Experience in audits and regulatory inspections
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Customer Quality Specialist - Rochester, United States - Unifin SAS
Description
Customer Quality SpecialistAbout Us:
We are a leading French pharmaceutical industrial group dedicated to creating accessible healthcare solutions that enhance and simplify the lives of patients worldwide.
With three decades of advanced technology expertise, we stand out as a global leader in sterile single-dose products with operations across 10 sites on 4 continents and a team of over 2000 professionals.
Since 2013, Unither Manufacturing LLC., situated in Rochester (NY), specializes in producing a variety of pharmaceutical products, including Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets, and Capsules, with a workforce of more than 280 employees.
Your Role:
As the Customer Quality Specialist, you will report to the Quality Assurance Manager and be responsible for handling and supporting problem investigations, change controls, and customer complaints for both sterile and non-sterile products. Your key responsibilities will include:
Responsibilities:
Requirements:
Compensation:
$65, ,000.00 USD
About Us:
We are a dynamic company driven by a spirit of victory and are dedicated to strong growth while fostering close relationships with both customers and employees.
Our culture is built on 5 core values: Respect, Responsibility, Trust, Courage, and Innovation, which we aim to instill in our team through autonomy, support for initiatives, and a conducive work environment.
Join us to make a meaningful impact in the healthcare industry and be part of a team that values excellence and responsibility.
Customer Quality Specialist professionals in Rochester
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Peyton Miles
Biology Graduate
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Jacob Boudreau
Software Development