Jobs for People with MS: National MS Society

Job Title

QA Inspector I/II/III

Organization Name

InvaGen Pharmaceuticals

Location

550 South Research Place Central Islip, NY 11722

7 Oser Ave, Hauppauge, NY 11788

Employment Type

(Hourly/ Full Time)

Full Time - Hourly/Non-Exempt

Salary Range

(Base/ Hourly)

Benefits

In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits

Work Hours/ Shift/ Remote

Shifts:

1st Shift - 7:00 AM - 3:30 PM

2nd Shift - 3:00 PM - 11:00 PM

3rd Shift - 11:00 PM - 7:00 AM

Responsibilities/ Accountabilities

The QA Inspector is responsible for monitoring and ensuring product quality is maintained through all phases of manufacturing or packaging in compliance with established specifications.

• Perform in-process testing (e.g., weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions.
• Perform room and equipment checks (where applicable) prior to each stage of manufacturing process as guided through written procedures.
• Perform AQL, Blend sampling, In-process Sampling, and inspections as required.
• Prepare in-process and finished product samples (where applicable) for QC lab, following detailed documentation procedures and delivering them to QC lab.
• Maintenance of standard weights and perform daily verification of balances which includes physically carrying ability of 100 kg (25 Kg x 4 No's) weights for multiple 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 (temperature and humidity data calibration and PM records, Pest control records and contractor related functions).
• Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step.
• Verification of functionality of all the equipment and associated controls during the batch run.
• Perform applicable testing and prepare reports for customer complaints.
• Identify and report any non-conformances/discrepancies to management if applicable.
• Other duties that management may assign from time to time.

Education Qualifications

• Must have a minimum of a High School Diploma or equivalent education credential (ex. GED) required.
• Proficiently speak English as a first or second language
• Proficiently communicate and understand (read and write) scientific work in English.
• Have excellent organization, learning and teaching skills required to work in teams.
• Working knowledge of Microsoft Office programs and other scientific based software

Experience

• Must have a minimum of three (3) years of pharmaceutical QA experience.

Skills/ Competencies

• Knowledge of good manufacturing practices and good documentation practices preferred.
• Ability to read, write and communicate effectively.
• Self-motivated, with the ability to work in fast-paced manufacturing environment and handle multiple tasks simultaneously.
• Excellent organization skills with strong attention to details skills.
• Strong fundamental mathematical skills and knowledge

Physical Requirements

• Work standing or walking unassisted for 75% or greater of an 8-hour period.
• Unassisted lifting up-to 35 lbs., may be required.
• Able to wear appropriate personal protective equipment at all times, when required.

Other Information

This role works in a cGMP laboratory or 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 laboratory or 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.

No remote work available & no relocation