Confidential
Director of Operations at MercVen Healthcare | Director of Recruitment at MercVen Staffing
QA Inspector I (3rd Shift) | Fall River, MA
Work Hours:
Third Shift | 11:00 PM to 07:30 AM (Shift time may vary per business needs)
Employment Type:
Full-Time | Hourly (Non-Exempt)
Reports To:
Quality Assurance Manager
About the Role We are seeking a QA Inspector I for a 3rd shift role within a regulated pharmaceutical manufacturing environment. The selected candidate will perform on-the-floor quality inspections, in-process testing, documentation review, and ensure compliance with cGMP, SOPs, and production quality standards.
This position supports product quality throughout all stages of manufacturing, including documentation integrity, batch record checks, environmental monitoring, and necessary inspections to ensure product compliance.
Key Responsibilities
Perform in-process tests such as weight, thickness, hardness, friability, disintegration, and related checks as per batch record instructions.
Conduct room and equipment line clearance and inspections prior to manufacturing steps.
Perform AQL sampling and inspections during production.
Inspect finished and in-process product samples and document results accurately for delivery to the QC laboratory.
Maintain logs and verification of daily balance and standard weights.
Ensure proper segregation and documentation of rejected material.
Assess engineering-related records such as temperature and humidity logs, pest control documentation, and preventive maintenance records.
Review batch records for completeness, reconciliation, yields, signatures, and documentation accuracy.
Validate equipment functionality during batch operations.
Prepare reports for customer complaints and support investigations.
Identify and escalation non‑conformances to QA management.
Complete additional tasks or project responsibilities as assigned.
Required Qualifications
Minimum education: High school diploma.
Minimum three years of experience in a cGMP pharmaceutical manufacturing quality assurance role.
Background in chemistry is required.
Strong written and verbal English communication skills.
Proficient in basic computer systems, MS Office, SAP or similar systems.
Strong analytical, documentation, and attention‑to‑detail skills.
Ability to work independently and collaborate in a team environment.
Must have experience in pharmaceutical quality; biopharmaceutical‑only experience will not be considered.
Preferred Qualifications
Advanced training or vocational education in industrial or pharmaceutical manufacturing.
Experience in MDI manufacturing is a plus.
Work Authorization Requirement
US Citizen or Green Card Holder only.
Seniority level Not Applicable
Employment type Full-time
Job function Quality Assurance and Manufacturing
Industries Pharmaceutical Manufacturing and Medical Equipment Manufacturing
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Work Hours:
Third Shift | 11:00 PM to 07:30 AM (Shift time may vary per business needs)
Employment Type:
Full-Time | Hourly (Non-Exempt)
Reports To:
Quality Assurance Manager
About the Role We are seeking a QA Inspector I for a 3rd shift role within a regulated pharmaceutical manufacturing environment. The selected candidate will perform on-the-floor quality inspections, in-process testing, documentation review, and ensure compliance with cGMP, SOPs, and production quality standards.
This position supports product quality throughout all stages of manufacturing, including documentation integrity, batch record checks, environmental monitoring, and necessary inspections to ensure product compliance.
Key Responsibilities
Perform in-process tests such as weight, thickness, hardness, friability, disintegration, and related checks as per batch record instructions.
Conduct room and equipment line clearance and inspections prior to manufacturing steps.
Perform AQL sampling and inspections during production.
Inspect finished and in-process product samples and document results accurately for delivery to the QC laboratory.
Maintain logs and verification of daily balance and standard weights.
Ensure proper segregation and documentation of rejected material.
Assess engineering-related records such as temperature and humidity logs, pest control documentation, and preventive maintenance records.
Review batch records for completeness, reconciliation, yields, signatures, and documentation accuracy.
Validate equipment functionality during batch operations.
Prepare reports for customer complaints and support investigations.
Identify and escalation non‑conformances to QA management.
Complete additional tasks or project responsibilities as assigned.
Required Qualifications
Minimum education: High school diploma.
Minimum three years of experience in a cGMP pharmaceutical manufacturing quality assurance role.
Background in chemistry is required.
Strong written and verbal English communication skills.
Proficient in basic computer systems, MS Office, SAP or similar systems.
Strong analytical, documentation, and attention‑to‑detail skills.
Ability to work independently and collaborate in a team environment.
Must have experience in pharmaceutical quality; biopharmaceutical‑only experience will not be considered.
Preferred Qualifications
Advanced training or vocational education in industrial or pharmaceutical manufacturing.
Experience in MDI manufacturing is a plus.
Work Authorization Requirement
US Citizen or Green Card Holder only.
Seniority level Not Applicable
Employment type Full-time
Job function Quality Assurance and Manufacturing
Industries Pharmaceutical Manufacturing and Medical Equipment Manufacturing
#J-18808-Ljbffr