GMP Incoming Materials Quality Inspector

ANIKA-GCC

Bedford (MA)

On-site

USD 32,000 - 41,000

Full time

14 days+

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Benefits offered by this job

Discretionary bonus program

Comprehensive healthcare benefits

Health savings account

401(k) plan with company match

Employee stock purchase plan

Paid time off

Long-term incentives

Job summary

Anika, based in Bedford, MA, is seeking a QC Materials Incoming Inspector to perform quality inspection and release activities for raw materials used in GMP manufacturing and packaging. The role requires a strong attention to detail and a solid understanding of GMP, QA/QC processes, and Good Documentation Practices.

Responsibilities include performing inspections, line clearances, and material releases, with ERP-based inventory transactions in SAP.

Qualifications

Associate’s degree in Life Sciences or equivalent.
Minimum of 1 year of experience in a QA/QC role within a regulated industry environment.
Experience using Microsoft Office applications and ERP systems.
Strong attention to detail and ability to follow established procedures and specifications.
Ability to document activities accurately and maintain compliance with Good Documentation Practices.

Responsibilities

Perform incoming material inspections according to approved procedures, specifications, and quality requirements.
Conduct quality line clearances and in-process inspections during inspection, packaging, and cartoning operations in accordance with SOP requirements.
Release approved raw materials for GMP manufacturing and packaging use through completion of required documentation, status identification, and ERP inventory transactions.
Update and maintain inventory transactions within SAP or equivalent ERP systems to support material control and traceability.
Monitor annual retain inspections, coordinate required retesting activities with Quality Control, and complete associated documentation.
Serve as a subject matter expert for incoming inspection activities and support training for new employees, contractors, and Quality personnel as needed.
Document work activities in compliance with Good Documentation Practices and applicable quality procedures.
Maintain current training qualifications for assigned procedures through classroom training, procedural review, and on-the-job training activities.
Support continuous improvement initiatives and participate in additional projects and assignments as needed.