GMP Quality Inspector — 2nd/3rd Shift

Osmotica Holdings Corp; Marietta (GA); Vor Ort; USD 42.000 - 65.000; Vollzeit

Zusammenfassung

Osmotica Holdings Corp. seeks a Quality Inspector 1 to support production floor activities in Marietta and/or Alpharetta, GA. Expect on-floor QA release, line clearance, and in-process record reviews to ensure proper documentation and cGMP compliance.

The role requires flexibility for second/third shifts and weekends, with close collaboration with operations to resolve quality concerns and maintain product integrity.

Qualifikationen

• Two years of GMP manufacturing experience.
• Knowledge of cGMP and FDA expectations.
• Strong documentation and communication skills.
• Proficient in Microsoft Office.

Aufgaben

• On the floor to provide quality oversight for all critical manufacturing and packaging processes.
• Perform QA release and line clearance inspections and AQL checks on product.
• Review on-floor logbooks and in-process batch records.
• Perform Label Control testing, issuance and reconciliation.
• Assist with pallet tags, Hold tags, and equipment out-of-service tags.
• Review batch records and prepare data for Annual Product Reviews or other projects.
• Identify deviations and ensure investigations are initiated by appropriate personnel.
• Communicate complex issues clearly to Management.
• Assist with creation/revision of SOPs reflecting current practices.
• Assist with FDA and other regulatory inspections.
• Adhere to Alora Quality Systems, site EH&S rules, and FDA/regulatory requirements.
• Maintain knowledge of current drug GMP regulatory requirements.
• Operate document control functions as needed.
• Perform annual retain inspections and release product contact supplies.
• Sample incoming raw materials and conduct retest testing.
• Test incoming printed materials against specifications.
• Perform additional duties as assigned.

Kenntnisse

GMP knowledge

Quality inspection

Documentation practices

MS Office

Ausbildung

High School Diploma

Jobbeschreibung

Osmotica Holdings Corp. seeks a Quality Inspector 1 to support production floor activities in Marietta and/or Alpharetta, GA. Expect on-floor QA release, line clearance, and in-process record reviews to ensure proper documentation and cGMP compliance.

The role requires flexibility for second/third shifts and weekends, with close collaboration with operations to resolve quality concerns and maintain product integrity.