QA Inspector II - 2nd Shift

Job Title: QA Inspector II - 2nd Shift
FLSA Classification: Full-Time, Non - Exempt Professional
Work Location: Fall River, MA
Work Hours: second Shift: 3:00 PM - 11:30PM (may vary based on business needs)
Reports To: Quality Control Manager


Job Purpose:
The purpose of the QA Inspector position is to monitor and ensure shop floor activities and ensure product quality is maintained throughout all phases of the manufacturing and packaging process in compliance with established specifications and standard operating procedures (SOPs).


Duties and Responsibilities:
The QA Inspector (MDI) position is an individual contributor role and a member of the Plant Quality Team. The essential and typically expected job duties for this position include but are not limited to the following:

• Working knowledge of shop floor QA activities (Line clearance, in-process checks, sampling, calibration and verification of equipment's).
• Perform line clearance, in-process testing as per batch record instructions.
• Review of batch records.
• Preparation, issuance and review of logbooks.
• Conduct room and equipment checks (where applicable) prior to each stage of manufacturing by following detailed written procedures.
• Execute sampling and inspections as required.
• Inspect in-process and finished product samples (where applicable) for the Quality Control (QC) Lab.
• Maintain records of standard weights and perform daily verification of balances.
• Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record.
• Monitor facility and product environmental operating conditions.
• Review of engineering records such as temperature and humidity data, calibration and PM records, Pest control records and contractor related functions.
• Assess online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step.
• Verify the functionality of all the equipment and associated controls during the batch run.
• Identify and report any non-conformances and/or discrepancies to management if applicable.

Education and Experience:

• Minimum high school diploma
• Advanced vocational training or education in pharmaceutical manufacturing, industrial management, or related field of study from an accredited college/university is preferred.
• Experience in quality assurance in a cGMP pharmaceutical manufacturing operation and work environment is preferred.
• Minimum of 3 years' experience in quality assurance in a cGMP pharmaceutical manufacturing operation and work environment.
• Experience in MDI or combination products is preferred.
• Proficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP, and other business applications.
• Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and goals.
• Effective interpersonal relationship skills and the ability to work in a team environment.
• Proficiency in the English language to include usage, spelling, grammar, and punctuation.
• Must have current Good Manufacturing Practices (cGMP) knowledge.
• Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed.
• Must have strong organization and leadership skills (written, verbal, and presentation).
• Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines.

Working conditions
This role works in a cGMP manufacturing environment, where personal protective equipment is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc. Work with or around solvents, powders, or other materials commonly found in a pharmaceutical manufacturing facility is required.The role may be assigned on a work-shift basis, where required (Day, Evening, Night). Weekend or Holiday work may be requested or required.


Physical requirements

• Work standing or walking unassisted for 75% or greater of an 8-hour period. Unassisted lifting up-to 10 kg, may be required.
• Able to always wear appropriate personal protective equipment, when required.
• Sitting at a desk and/or working at a computer or other "screen" 75% or greater of an 8-hour period.

Professional and Behavioral Competencies:

• Must be willing to work in pharmaceutical manufacturing and packaging quality assurance.
• Must be willing and able to work any assigned shift ranging from first or second shift. Work schedule may be Monday to Friday.
• Must be willing to work some weekends based on business needs as required by management.
• No remote work available.

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