Quality Operations Inspector I

Summary: QO Inspector I will provide support to the Production and Packaging groups. The job includes control and distribution of pre-printed labels, status labels and creation of in-house printed labels to support various production operations. Additionally, will support inspection and release of components utilized to support various production activities.

Essential Duties and Responsibilities include the following:

• Apply good documentation knowledge to ensure that all logbooks and batch record entries are accurate and in compliance with cGMPs.
• Work independently and ensure that label creation, staging, and distribution are prioritized.
• Apply critical thinking skills when responding to requests for labels to prevent errors.
• Maintain completed Receiving, Inspection and Reconciliation documentation.
• Assist Inventory Control in maintaining accurate label counts in Navision.
• Receipt and inspection of labels, controlled documents in accordance with Quality policies.
• Perform count of the label roll received from the vendor for quantity verification.
• Creation of typesets for the applicable equipment(s).
• Prepare and print status labels such as Released, Reject, Quarantine Hold, etc.
• Reconcile the in-house labels that were issued to Packaging by ensuring the rejected, used, and returned labels are consistent and accounted for with the Packaging Batch Record.
• Follow cleaning schedule of the area and label room according to established procedures.
• Report label status on a weekly basis for scheduling purposes.
• Place purchase orders to the purchasing department when stock is running low of the blank stock’s labels.
• Track and record humidity and temperature in the label room and update the chart recorder paper on a weekly basis.
• Perform component inspections.
• May be required to perform other duties as assigned or as needed.

Supervisory Responsibilities: None

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience:

• High School diploma.
• 1+ years of experience in GMP regulated environment.
• Equivalent combination of education and experience may apply.

Knowledge, Skills, and Abilities:

• Ability to apply an understanding of cGMP requirements.
• Ability to perform well under schedule requirements.
• Superior attention to detail and ability to maintain consistency.
• Strong interpersonal communication with Manufacturing, Quality, and Inventory personnel.
• Strong organizational skills.
• Use of Microsoft Office software, i.e., Word, Excel; and Weber label printers a plus.

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 this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms. The employee is frequently required to stand, walk, talk and hear. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is frequently exposed to fumes or airborne particles. The employee is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually moderate.