Quality Assurance Inspector - Osmotica Pharmaceuticals

Osmotica; Marietta (GA); On-site; USD 42,000 - 65,000; Full time

Job summary

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.

Qualifications

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

Responsibilities

• 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.

Skills

GMP knowledge

Quality inspection

Documentation practices

MS Office

Education

High School Diploma

Job description

POSITION DETAILS

Position Title: Quality Inspector 1

Function: Quality

Reports To: Supervisor, Quality Operations

Location: Marietta and/or Alpharetta, GA

POSITION OVERVIEW

The Quality Inspector 1 is primarily responsible for supporting activities on the production floor. This includes room release, line clearance, in-process batch record review or post-executed review to ensure proper good documentation practices are followed. Provide quality oversight to all production areas to ensure product quality and compliance to cGMPs. This person works closely with operations personnel ensuring cGMP concerns are identified and resolved appropriately. Must be available/flexible to work second or third shift and weekends.

DUTIES AND RESPONSIBILITIES

• Required to be on the floor and present to provide quality oversight for all critical manufacturing and packaging processes.
• Perform QA release and line clearance inspections and AQL checks on product.
• Performs on the floor logbook and in-process batch record review
• Perform Label Control functions (testing, issuance and reconciliation).
• Assist in the application and removal of pallet tags, Hold tags, and equipment out of service tags.
• Conduct review of batch records.
• Accumulate and organize data for Annual Product Reviews or other projects, as assigned by management.
• Identify deviations and ensure investigations are initiated by the appropriate personnel.
• Clearly communicate complex issues to Management personnel.
• Support creation / revision of SOPs to reflect current practices.
• Assist with FDA and other regulatory inspections.
• Perform all activities in compliance with Alora Quality Systems, site environmental, health, and safety rules; and applicable FDA and international regulations.
• Maintain knowledge of current regulatory requirements pertaining to drug product manufacture and packaging (cGMPs).
• Perform document control functions as needed.
• Perform annual retain inspections
• Release product contact supplies
• Perform sampling of incoming raw materials and for raw material retest.
• Test incoming printed materials against established specifications.
• Perform additional duties and responsibilities as assigned.

EXPERIENCE AND QUALIFICATIONS

• High School Diploma or equivalent or technical school certificate.
• Two years of experience in, or support of, pharmaceutical or biotech GMP manufacturing.
• Proficient knowledge of a GMP production facility, manufacturing processes, and/or inspection processes.
• Demonstrated understanding and application of cGMP, current industries practices and relevant guidance.
• Excellent written and verbal communication skills.
• Ability to multi-task effectively.
• Position requires the ability to work independently and effectively in all areas of communication, collaboration, and decision-making.
• Great attention to detail with ability to work on multiple projects.
• Ability to organize and adapt to organization priority changes and work effectively under occasional peer or management supervision with a sense of urgency.
• Proficient in Microsoft Office (Word, Excel).

Preferred Experience / Skills

• Quality Assurance experience

OTHER REQUIREMENTS

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the essential duties of this job the employee is frequently required to stand, walk, and reach with hands and arms. Employee may be required to inspect pharmaceutical equipment which includes crouching to look under equipment and/or contorting to examine difficult to view areas. The employee is regularly required to sit, use the hands and fingers to type via the use of the PC (Personal Computer). Must be able to lift and move up to 20 lbs. Periodic/infrequent travel to sister sites may be required. No Personal Protective equipment required, unless entering in-process production areas.

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.