Quality Assurance Technician
Actalent
Job Title: Quality Assurance TechnicianJob Description
The Quality Assurance Technician will perform in-process quality checks, including weight, thickness, hardness, disintegration, and friability, according to the instructions in the manufacturing batch record. The role involves conducting pre-manufacturing inspections of rooms and equipment, carrying out Acceptable Quality Limit (AQL) sampling and inspections, and inspecting in-process and finished product samples for the Quality Control (QC) Lab. The position requires maintaining standard weight records, performing daily balance verifications, and properly isolating and documenting any rejected materials. The technician will also monitor environmental conditions affecting facility and product quality, review engineering documentation, evaluate online batch records, and confirm the functionality of equipment during batch runs.
Responsibilities
+ Perform in-process quality checks, including weight, thickness, hardness, disintegration, and friability.
+ Conduct pre-manufacturing inspections of rooms and equipment.
+ Carry out Acceptable Quality Limit (AQL) sampling and inspections.
+ Inspect in-process and finished product samples for Quality Control (QC) Lab.
+ Maintain standard weight records and perform daily balance verifications.
+ Properly isolate and document any rejected materials generated during batch processing.
+ Monitor environmental conditions affecting facility and product quality.
+ Review engineering documentation, including temperature/humidity logs, calibration and preventive maintenance records.
+ Evaluate online batch records for completeness and accuracy before proceeding to the next processing step.
+ Confirm the functionality of all equipment and control systems during batch runs.
+ Conduct relevant testing and prepare reports in response to customer complaints.
+ Identify and escalate any non-conformances or discrepancies to management.
+ Perform additional duties or participate in special projects as assigned by management.
Essential Skills
+ Experience in quality assurance within a GMP-compliant pharmaceutical manufacturing environment.
+ Knowledge of quality assurance, pharmaceutical manufacturing, deviation, and document control.
+ Familiarity with HPLC, GC, Karl Fisher, Quality Validation, and GMP.
+ Experience with metered-dose inhalers (MDIs) or parenteral products is highly desirable.
+ Proficient in using personal computer hardware and software applications such as Microsoft Office tools and SAP.
+ Ability to influence decision-making and facilitate work completion.
+ Strong interpersonal relationship skills and the ability to work in a team environment.
+ Proficiency in the English language, including usage, spelling, grammar, and punctuation.
+ Knowledge of current Good Manufacturing Practices (cGMP).
+ Self-starter with initiative to seek additional training or direction as needed.
+ Strong organization and leadership skills, both written and verbal.
+ Detail-oriented with the ability to multitask and prioritize tasks with strict deadlines.
Additional Skills & Qualifications
+ Completion of advanced vocational training or a degree in pharmaceutical manufacturing, industrial management, or a related discipline from an accredited college or university is preferred.
+ 2-3 years of experience in a similar role.
Work Environment
The role operates on a first shift from 8:30 AM to 5:00 PM, Monday through Friday. The technician will work as part of a support team of 15-20 people with cross-collaboration with manufacturing. The position reports directly to the QA Manager and requires standing or walking unassisted for 75% or more of an 8-hour period. Unassisted lifting of up to 10 kg may be required. The technician must wear appropriate personal protective equipment when necessary and may spend 75% or more of the time sitting at a desk or working at a computer.
Pay and Benefits
The pay range for this position is $65000.00 - $73000.00/yr.
Health, Vision, Dental, 401K
Workplace Type
This is a fully onsite position in Fall River,MA.
Application Deadline
This position is anticipated to close on Jul 17, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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