QC Incoming Inspector I

Location: Bedford, MA

Summary of Primary Responsibilities:

The QC Incoming Inspector completes all activities required to approve raw materials for use in product manufacture. The position also performs inspection activities during in-process manufacturing.

Specific Responsibilities:

  • Perform quality line clears and in process inspections during the inspection and packing processes according to specific SOP requirements
  • Issue lot numbers and control labels for incoming raw materials; perform inspections per internal procedures and specifications
  • Release approved raw materials for use in manufacturing process to include completion of associated documents, notice of approval form (bin card) and relabeling of inventory
  • Review MPS of other incoming inspectors for approval and release.
  • Monitor and perform annual retain inspection; coordinate required retesting with QC; complete required documentation
  • Perform OOS investigations and participate in MRB as required for rejected materials
  • Perform as SME for the function and provide training as required to new employees, contractors and other QA personnel
  • Perform biennial review for designated procedures and MPS as needed
  • Documents; author and complete DCR as required
  • Document all work activities according to Good Documentation Practices
  • Maintain current training on all assigned procedures to include read & understood, skills development and classroom training activities as required
  • Participate in other projects as assigned

Job Complexity:

The position works on assignments that are routine in nature and receives detailed instruction on all work.

Supervisory Responsibilities:

None

Required Qualifications:

  • Associates degree in the life science or relevant work experience
  • 0 – 1 year of experience in a cGMP facility or previous experience in a QA/QC role within the industry; internship experience considered
  • Experience using Microsoft Office or an ERP system

Desired Experience, Knowledge, and Skills:

  • Bachelor’s degree preferred
  • Experience working in a clean room environment
  • Excellent communication and documentation skills
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We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.

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