Description

Summary:

Monitors and measures quality on packaging lines to assure proper monitoring of fill weights, torque specifications, labels and packaging components along with various quality functions to assure that production produces a good quality product. This person is capable of performing the job tasks of ONE QA function such as clerk or auditor. This person is confident in communicating with internal customers.

Essential Duties and Responsibilities:

Review all Compounding, Packaging and QC paperwork & major computer transactions for adherence to customer specifications and regulatory requirements. Release finished goods inventory for distribution in the computer system. Reject non-conforming finished goods inventory in the computer system. (QA Doc)

Review and release/reject incoming customer returns in the computer system. (QA Doc)

Sample all incoming raw materials or components. This includes reviewing the lab results for accuracy and releasing or rejecting the material in the computer system. (Receiving Inspection or Auditors (TN Only for Raw Materials)

Sample and test all incoming containers & closures. Release or reject containers and closures in the computer system. (Receiving Inspection or Auditors)

Inspect incoming labels for conformance to customer specifications and regulatory requirements. (QA Label Tech or Auditors)

Conduct process audits to ensure adherence to cGMPs, FDA guidance documents and customer specifications. This includes auditing all areas directly or indirectly involved in the manufacturing of drug products; Compounding, Packaging, Receiving, Distribution, QC labs, etc.…. (Auditor)

Conduct product audits to ensure the in-process and packaged product meets customer specifications and cGMPs. This includes inspecting product on the Packaging lines and identifying and reporting non-conforming material. (Auditor)

Conduct Tank cleanliness verifications and review logbooks in compounding (Auditor)

Maintain an audit tracking system for the department. (Auditor)

Responsible for issuing all shop floor paperwork from SAP and SOP intranet system to packaging floor. This includes printing and issuing case labels to packaging and outsourced suppliers. (Label Control or Clerk)

Responsible for receiving and issuing all pre-print and seals to the packaging floor and contract packaging. This includes receiving returned labels and cycle counting of inventory. (Label Control or Clerk)

Handles label vendor returns, destruction of defective or obsolete labeling. (Contract Packaging is MO only). (Label Control or Clerk)

Operate rewind equipment. (Label Control or Clerk)

Calculate and enter information from the Direct Labor sheet. (Label Control or Clerk)

Issue formulas to PM work orders by batch. (Label Control or Clerk)

Assure that all paperwork is accurate and complete prior to turning into the Doc Center. (Label Control or Clerk)

Forklift Certification is required for working in the Distribution Center. (QA Distribution Center)

Must be able to operate an electric pallet jack on a daily basis (SOME)

Facilitate with QA Management final disposition of Quarantined and Non-Conforming Materials. (All QA)

Be flexible and able to work in all QA areas as assigned. (All QA)

Organize and maintain retain samples and batch records in accordance with cGMPs. (All QA)

Ensure that all samples are pulled and delivered to the QC Lab as needed. (All QA)

Report any documentation errors, out of tolerance reconciliation issues for investigation and corrective action to the supervisor. (All QA)

Supervisory Responsibilities: N/A

Education Requirements:

High School Diploma or GED is required. Two years of college level course work is preferred or equivalent knowledge in math, science and computers achieved from work experience and/or on-the-job training.

Experience Requirements:

Minimum of 2 years' experience in a cGMP regulated industry is preferred. Ability to work in Microsoft programs (Word, Access, and Excel) and an ERP system is required.

Competencies:

• Works well with computers (ability to input or create spreadsheets, databases, etc.)
• Demonstrated ability to handle multiple tasks.
• Requires excellent oral & written communication skills.
• Ability to communicate cGMP standards to multiple departments.
• Ability to train associates on cGMPs. Excellent organizational skills and attention to detail.

Certificates, Licenses, Registrations: N/A

Travel: N/A

Work Environment:

Worker exposed to extreme heat and cold with temperatures sufficiently high or low to cause marked bodily discomfort. Exposed to sufficient noise to cause worker to shout in order to be heard above the ambient noise level. Worker exposed to hazards such as proximity to moving mechanical parts. Works in laboratory, production line and warehouse environments.

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 talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms. Occasionally lift boxes of products 5-40 lb. frequently lift samples 1-5 lb. Clarity of vision at 20 inches or less, with the critical ability to distinguish colors and adjust eye to bring objects into sharper focus.