Quality Control

  • location: Newark, DE
  • type: Contract
  • salary: $22 - $25 per hour

job description

Quality Control

Job Title: QC Biotechnician I

Job Responsibilities :

Completes timely and efficient quality control laboratory testing for intermediate control and release of final product. Maintains documentation, equipment and laboratory space in compliance with GMP & ISO 13485 standards. Assists in identification and implementation of continuous improvement initiatives.

QC Biotechnician II

Responsibilities and Duties:

  1. Perform QC testing as per production schedule with strict adherence to Manufacturing Batch Records and SOPs. Completes documentation in a timely manner and develops new and/or improved methods and SOPs for product QC testing.
  2. Maintain laboratory and equipment according to internal procedures and GMPs.
  3. Supports internal investigations, customer, and supplier audits.
  4. Maintains and analyzes quality records and logs to identify anomalies and trends, and monitor completion of action items.
  5. Performs verifications of the QC work and documentation of peers as needed.
  6. Utilizes systems for tracking project status and results of testing. (SAPA, Intelex, etc.)
  7. Generates Certificate of analysis for each product to be released based on internal and customers specifications.
  8. Responsible for investigating non-conforming issues within QC department.
  9. Perform additional job duties necessary within manufacturing areas as assigned.
Qualifications : (Knowledge, Skills and Abilities: Education, Experience, Job Skills, Equipment Skills, and Certifications)

  1. BS/BA in a life sciences discipline (i.e. Biochemistry, Medical Technology, Biology).
  2. Minimum of 2 years laboratory testing/QC experience working in a regulated environment.
  3. Working knowledge cGMP & ISO 13485.
  4. Working knowledge of biological processing and QC methodology (e.g. ELISA, RID, HPLC, Clinical Analyzers, SDS-PAGE, IEF, IHC, Isotype).
  5. Proficient with general laboratory methods, equipment and aseptic technique.
  6. Computer literacy to include Office products.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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