Quality Assurance/Control Analyst

Open Scientific; Town of Islip (NY); On-site; USD 18,000 - 22,000; Full time

Job summary

Open Scientific on Long Island is seeking a Detail-oriented QA Floor Inspector to support pharmaceutical production. The role focuses on reviewing in-process data and batch records to ensure cGMP and SOP compliance, guiding operations on quality practices, and helping release batches.

Candidates should have prior quality experience, strong organization, and familiarity with AS400, Captiva, and PDM tools. The position involves on-site work in a production environment with exposure to powders and

Qualifications

• High organizational skills and attention to detail.
• Excellent written and verbal communication.
• Strong computer skills including MS Office.
• Ability to lift up to 50 lbs and work on the production floor.

Responsibilities

• Investigate discrepancies or adjust errors.
• Approve pre-start-up activities including line/room clearance when required.
• Perform in-process testing verifications of operations data.
• Review in-process batch documentation for compliance with specs and cGMP.
• Discuss errors with line personnel for timely corrections.
• Collect data on FPQ and release batch records.
• Perform daily compliance audits for responsible areas.

Skills

Quality assurance

GMP/cGMP knowledge

SOP adherence

Documentation review

MS Office

Education

High school diploma or GED

Tools

AS400

Captiva

PDM software

Job description

Open Scientific provides contract staffing and direct hire recruitment services for the scientific, engineering, laboratory and manufacturing sectors.

Job Description

Pay rate is $13-$16

A pharmaceutical company is seeking Quality Control/Assurance personnel for their Long Island facilities. Main responsibilities include packaging pharmaceutical products following all SOPs and GMPs. The right candidate should have prior quality experience.

The QA Floor Inspector provides review of in-process test data and batch documentation in order to limit the need for later review or rework. The QA Floor Inspector is the Quality expert on the production floor and will guide and advise operations associates as necessary on cGMP’s and Good Documentation Practices to ensure timely release of product or reaction to issues.

Responsibilities include:

• Investigate discrepancies or adjust errors.
• When required, conduct approval of pre-start-up activities including line/room clearance, and initial equipment checks.
• When required, perform in-process testing verifications of operations data to confirm consistency in testing methodology and test data.
• Consistently review in-process batch documentation to ensure real-time compliance to product specifications, good documentation practices, company SOP’s and cGMP’s.
• Discusses errors directly with line personnel so corrections can be made if required.
• Collect data on FPQ and performs release of batch records.
• Perform daily compliance Audit for responsible areas within production.
• Responsible for conducting duties in compliance with safety rules, applicable SOP’s, and cGMP Guidelines.
• Experience with production equipment functionality and Quality Assurance Systems is preferred.
• Experience working with computer software such as AS400, Captiva and PDM software is preferred.
• Work environment may be exposed to powders, chemicals and allergens

Requirements include:

High organizational skills, required.

High attention to detail is required.

Excellent written and oral interpersonal communication skills, required.

Intermediate to advanced computer knowledge of MS Office programs (Outlook, Excel, and Word) is required.

Physical ability to repetitively lift (up to 50 lbs.), stand, bend, climb, etc. within an operations environment is required.

High school diploma or general education degree (GED) is required.

Complies with company policies and procedures and maintains exceptional work attendance.

Understanding of mathematical functions, such as mean, median, average, and standard deviation is preferred.

Additional Information

All your information will be kept confidential according to EEO guidelines.