Company
manufacturing
PackagingAssociateII
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Packaging Associate II. Skills: GMP compliance, Quality inspections, documentation review, packaging process. Verify systems and processes compliance. Conduct attribute inspections”
What You'll Achieve.
Ensure systems and processes are compliant; Ensure production activities begin and finish within specified time; Impact company compliance with regulatory requirements; Impact customer satisfaction
Industry & Context.
3rd Shift Hours: 11:00pm-7:00am, Must be able to stand for long periods of time, Occasionally lift and/or move up to 30 pounds, Subject to mandatory overtime, Regularly exposed to moving mechanical parts, Moderate noise level
What They're Looking For.
Must Have
High School Diploma or GED required, Good documentation and communication skills are required, Highly attune and focus on attention to detail is required, Good organizational and planning skills are required
Nice to Have
Some college education desired, Knowledge of FDA regulations related to cGMP is desired, Prior experience within a manufacturing or alike assembly process preferred, General knowledge of quality control processes is desired, Successful completion of the Quality@Source (Q@S) training assessment for the Quality In-Process Inspections as assigned to this position
What You'll Do.
Verify systems and processes compliance
Conduct attribute inspections
Perform asset verifications
Manage component delivery and removals
Enforce GMP compliance
Perform Quality inspections
Verify component attributes
Read and understand process steps
Ensure compliance during packaging
Assist with production efficiency
Inspect units for quality
Perform quality inspections per packaging record
Verify accuracy and completeness of documentation
How You'll Work.
Communication Scope
Good communication skills
Full Job Description
**3rd Shift Hours: 11:00pm-7:00am** **SUMMARY:** 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 to 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 with regulatory requirements and customer satisfaction. * Read and understand process steps within the packaging record to ensure compliance during the packaging process. * Assist where needed with the overall efficiency of the production within the assigned room or rooms. * 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. * Pre-start Equipment Room Check and Area clearance pages * Pre-Post Production Pages * Pre-Packaging Steps * Equipment Verification page(s) * Equipment / Component Startup Verification page(s) * Challenges * In-Process Inspections * Quality Samples * Reconciliation * Check weigher Sheets
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