At Sharp, our work matters. We are made up of two dynamic international divisions, Sharp Packaging Solutions and Sharp Clinical Services which work with clients across the world to create unique commercial and clinical solutions for the pharmaceutical and biotechnology industries. This position will function as lead associate responsible for verifying that all systems and processes are compliant with Work Instructions and Company requirements in order to begin and/or finish production activities within a specified room or rooms. Throughout production conduct attribute inspections, asset verifications and component delivery and removals according the requirements outlined in the associated Batch Record or MPR. ESSENTIAL DUTIES AND RESPONSIBILITIES The following is a list of minimum responsibilities related to the Packaging Associate II position. Other duties may also be assigned.
- Adherence to and enforcement of GMP compliance, performing Quality inspections (equipment challenges and verification, components, bulk product, work-in-process and finished goods) related to contract packaging, reviewing documentation and verifying component attributes.
- The impact of the quality inspection process directly impacts company compliance to regulatory requirements and customer satisfaction.
- Read and understand process steps within the packaging record to ensure compliance during the packaging process.
- Inspect units for quality as they are packaged.
- Responsible for performing quality inspections as required per the packaging record and per AQL requirements. Inspections may include visual, functional, destructive and count checks.
- Verify the accuracy, completeness and supported documentation of the packaging requirements outlined below and ensure all are supported by the appropriate documentation within the Batch Record.
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 or GED required. Some college education desired.
- Knowledge of FDA regulations related to cGMP is desired.
- Prior experience within a manufacturing or alike assembly process preferred
- Good documentation and communication skills are required.
- General knowledge of quality control processes is desired.
- Highly attuned to and focus on attention to detail is required.
- Good organizational and planning skills are required.