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Quality Systems Specialist

Job in Solon - Cuyahoga County - OH Ohio - USA , 44139
Company: Oakwood Labs
Full Time position
Listed on 2021-03-20
Job specializations:
  • Pharmaceutical
    Pharma Business Analyst, Pharmaceutical QA
  • Quality Control
    Pharmaceutical QA, QA Specialist
Job Description & How to Apply Below
This position is an excellent opportunity for a quality minded individual interested in working in a technology-based pharmaceutical company.

Attributes required for the position

* Two years experience in an FDA regulated or ISO (high-tech) manufacturing environment
* Experience in the Quality Systems discipline, including root cause investigations and CAPA
* Bachelors Degree in a science related field or equivalent experience

Description of work to be performed

* Manage approval of initiated deviations, investigations, complaints, OOS/OOT and CAPA reports
* Perform initial impact assessment for exception documents
* Track completion of outstanding exception documents and maintain metrics for completion
* Complete annual product reviews for commercial products
* Complete continuous process verification for commercial products
* Perform statistical analysis to support various quality systems

Oakwood Labs is a privately owned specialty pharmaceutical company focused on the design, development, and commercial manufacture of sterile injectable sustained-release microsphere products. This unique class of medications delivers therapeutic levels of drug to patients over days, weeks, months, or a year with a single intramuscular or subcutaneous injection. Products of this class have extremely high commercial potential. We offer a competitive benefits and salary package.
Position Requirements
Less than 1 Year work experience
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