Quality Line Auditor

Description

(include responsibilities, decisions, and/or recommendations for each task)

Frequency

(daily, weekly, monthly, quarterly, annual)

Undergo GMP Training and Follow Standard Operating Procedures.

D

Know and observe all Safety requirements.

D

Retrieve all customer samples ensuring that they comply                                                                       with all specifications and meet customer expectations.

D

Able to read all specifications defined on the Work Order.  These include, but not limited to, weights, crimps stacking patterns and codes.

D

Ensure that line clearance has been performed and documented at the start of the production run and/or shift.

D

Description

(include responsibilities, decisions, and/or recommendations for each task)

Frequency

(daily, weekly, monthly, quarterly, annual)

Review all quality documents generated during in process check within shift.  Ensure that any out of spec material has been dispositional.

D

Inform Quality Lead Tech of any issues that may arise during shift.

D

Comply with written procedures and enforce GMPs.

D

Perform audits of all filled product as needed or specified by the customer.

D

Retrieve micro samples and retain samples as stated in the Work Order.

D

Prepare all in-process documentation for the production line as needed for each production run.

D

Ability to perform and document all in-process measurements and inspections required while producing product on the production line they are assigned.

D

Ability to use and calibrate gauges, equipment, and tools as required for in-process checks.

D

Ability to prepare fill weights on a liquid line using the specific gravity.

D

Prepare Checkweigher low, high and target standards.

D

Verify all components are correct and approved for use while filling product.

D

Compile and review all in-process paperwork for quality checks performed on the line during production.

D

Must accurately review line inspections and ensure that rechecks are performed and Out of Specification (OOS) results are addressed when they occur.

D

Must closely monitor assigned lines to ensure that line personnel are conducting the tests correctly and that the testing is performed in a timely manner.

D

Must closely monitor assigned lines to ensure compliance to all written procedures and GMPs.  This includes the overall monitoring of personnel and the production process to ensure that the GMPs and procedures are followed.

D

Assist in training line personnel.

M

Perform additional duties as required by the Quality Assurance Lead or Quality Management.

D

Activity

Frequency

Description of Tasks

Sitting

                    S

Standing

                    F

Walking

                    C

Driving

                    N

Lifting (up to 50 ) lb.

                    O

Carrying ( 15) lb.

                    F

Pushing/Pulling (up to 50)  lb.

                    O

Climbing Stairs/Ladders

                    F

Bending/twisting at waist

                   C

Kneeling/squatting

                   O

Crouching/Kneeling

                   O

Crawling

                   S

Reaching above shoulder

                   S

Repetitive Motion

                   C

Handling/Grasping

                   C

Fine Finger Manipulation

                    F

Talking

                    F

Hearing

                   O

Seeing

                   C