Spectrum Staffing Services/HRStaffers Inc.
Quality Assurance Manufacturing Specialist
Spectrum Staffing Services/HRStaffers Inc., Netcong, New Jersey, us, 07857
Quality Assurance Manufacturing Specialist
This range is provided by Spectrum Staffing Services/HRStaffers Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $25.00/hr - $30.00/hr
SUMMARY Join a growing and trusted pharmaceutical organization dedicated to advancing quality in sterile drug production. As a QA Manufacturing Specialist, you’ll provide direct quality oversight of production operations, ensuring alignment with cGMP guidelines as defined under Section 503B. This role supports compliance in compounding, filling, inspecting, and packaging processes by monitoring critical procedures and documentation. Ideal for detail-driven individuals eager to contribute to regulatory excellence and patient safety.
RESPONSIBILITIES
Monitor daily production floor activities including compounding, aseptic filling, visual inspection, and packaging to uphold quality standards
Ensure cleaning protocols are thoroughly followed and documented in manufacturing areas
Approve product labels and ensure compliance prior to use
Conduct verification of line clearance, material status, aseptic techniques, and documentation during filling operations
Ensure personnel follow proper gowning procedures across all production zones
Identify and document quality events such as deviations, initiate CAPAs, and manage change controls
Represent QA interests during audits and inspections as neededAssist with root cause investigations to drive continuous improvement
Maintain detailed and accurate batch records, logs, and compliance documentation
Adhere to company policies and support additional duties as needed
QUALIFICATIONS
Minimum 3 years of experience in quality assurance within aseptic drug manufacturing, preferably in a 503B outsourcing facility
High school diploma required; BS in a scientific discipline preferred
Solid understanding of cGMP, Good Documentation Practices, and pharmaceutical quality systems
Knowledge of manufacturing operations, automation, and cleanroom practices
Proficient in Microsoft Office (Word, Excel, PowerPoint); ability to learn new systems as required
Effective communication skills with ability to work independently and under time‑sensitive conditions
Adaptable to rotating shifts, weekend schedules, and holiday coverage if required
Physical ability to lift up to 25 pounds and wear required cleanroom attire, including scrubs, gloves, and safety footwear
Comfortable working in cleanroom environments and with hazardous substances as necessary
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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Base pay range $25.00/hr - $30.00/hr
SUMMARY Join a growing and trusted pharmaceutical organization dedicated to advancing quality in sterile drug production. As a QA Manufacturing Specialist, you’ll provide direct quality oversight of production operations, ensuring alignment with cGMP guidelines as defined under Section 503B. This role supports compliance in compounding, filling, inspecting, and packaging processes by monitoring critical procedures and documentation. Ideal for detail-driven individuals eager to contribute to regulatory excellence and patient safety.
RESPONSIBILITIES
Monitor daily production floor activities including compounding, aseptic filling, visual inspection, and packaging to uphold quality standards
Ensure cleaning protocols are thoroughly followed and documented in manufacturing areas
Approve product labels and ensure compliance prior to use
Conduct verification of line clearance, material status, aseptic techniques, and documentation during filling operations
Ensure personnel follow proper gowning procedures across all production zones
Identify and document quality events such as deviations, initiate CAPAs, and manage change controls
Represent QA interests during audits and inspections as neededAssist with root cause investigations to drive continuous improvement
Maintain detailed and accurate batch records, logs, and compliance documentation
Adhere to company policies and support additional duties as needed
QUALIFICATIONS
Minimum 3 years of experience in quality assurance within aseptic drug manufacturing, preferably in a 503B outsourcing facility
High school diploma required; BS in a scientific discipline preferred
Solid understanding of cGMP, Good Documentation Practices, and pharmaceutical quality systems
Knowledge of manufacturing operations, automation, and cleanroom practices
Proficient in Microsoft Office (Word, Excel, PowerPoint); ability to learn new systems as required
Effective communication skills with ability to work independently and under time‑sensitive conditions
Adaptable to rotating shifts, weekend schedules, and holiday coverage if required
Physical ability to lift up to 25 pounds and wear required cleanroom attire, including scrubs, gloves, and safety footwear
Comfortable working in cleanroom environments and with hazardous substances as necessary
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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