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 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.
- 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
- Product/Component Transactions Waste logs
- TOR Logs as Applicable
SUPERVISORY RESPONSIBILITIES This job has no supervisory responsibilities.
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 attune and focus on attention to detail is required
- Good organizational and planning skills are required.
Successful completion of the Quality@Source (Q@S) training assessment for the Quality In-Process Inspections as assigned to this position.
LANGUAGE SKILLS Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to effectively interact with associates at all levels within the organization. Must be comfortable with speaking out when processes, actions or outputs are not consistent with policy or work instructions. Daily contact with Quality and Operations departments related to Quality and cGMP.
MATHEMATICAL SKILLS The ability to apply basic mathematical operations to assigned tasks is required; this includes an understanding of statistical sampling plans, and the ability to calculate time, percentages and decimals. Basic math skills (addition, subtraction, multiplication and division) are required.
REASONING ABILITY The ability to make rational decisions pertaining to quality compliance and operational efficiency is required. The ability to resolve problems effectively and efficiently is required.
WRITTEN SKILLS: The ability to provide clear, concise and legible documentation within batch records and forms in conformance with basic Good Documentation Practices is required.
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 handle or write and to speak and hear. The employee frequently is required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 30 pounds. The employee may be subject to mandatory overtime if scheduling requires. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.
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 normally required to stand for long periods of time within a production room. The employee is regularly exposed to moving mechanical parts. The noise level in the work environment is usually moderate. The working environment is clean and not normally subject to hazardous environment or conditions.