PKG operators

Packaging Operations Dayton, New Jersey


Description

 

 

Name:

 

JOB TITLE:Packaging Operator                EFFECTIVE DATE:

REPORTS TO:SupervisorDEPT: Production

 

SUPERVISES:NoneLOCATION:  6 Wheeling, Dayton, NJ

(number of employees) 2400 Route 130N, Dayton, NJ

Other: ____________________

 

 

JOB SUMMARY

 

This Employee is responsible to ensure that the packaging line and the equipments on packaging line are clean and set up properly.  Also to ensure quality produced finished product is according to Production Batch Record instructions.

Essential Functions:
 

Employee’s responsibility includes:

  1. Follow company policies, cGMP’s and Standard Operating Procedures.
  2. Clean and/or disassemble packaging line and equipments e.g. Unscrambeler, desiccant inserter, tablet counter, cotton inserter, capper,  induction sealer, retorquer, labeler, outserter, shrink wrap after the completion of packaging process as per SOP.
  3. Clean manufacturing room after the completion of product run as per SOP.
  4. Set up packaging line and equipments, including start up of batch and obtaining all packaging specifications.
  5. Maintain packaging line and equipments in good working order, inspect packaging line and equipments for wear, and have any worn or malfunctioning parts evaluated and reported to Production Supervisor or Manager.
  6. Maintain tools and supplies in proper condition.
  7. Make any machine adjustments necessary during the packaging run as required.
  8. Document all set up and cleaning in the log book and other pertinent paperwork.
  9. Visually inspect the equipments as it is running to verify the equipments are running within normal and safe operation.
  10. Perform in process checks during packaging process and document in Packaging Batch Record as per instruction of packaging batch record.
  11. Make sure all paperwork is complete and accurate throughout and after run.
  12. Perform any and all additional tasks relating to the operation of the packaging/production department as requested.

 

 

  1. Physical Work Activities and Exposure:

 

A)     Work is regularly performed inside in a manufacturing environment.

B)     Exposure to dust, odor, noise, and fumes.

C)     The noise level is usually moderate.

D)     Must frequently lift and/or move up to 50 pounds and occasionally lift and/or move up to 75 pounds.

E)      Frequent sitting, talking, or hearing.

F)      Use hands to finger, handle, feel, or operate objects or controls.

G)     Walk short distances. Clean and/or disassemble packaging equipments after the completion process.

 

REPORTING RELATIONSHIPS

NA

 

 

 

DUTIES & ESSENTIAL JOB FUNCTIONS

Identify the functions or tasks that employees in the job perform. The essential functions should state the purpose of the work and the results to be accomplished, rather than how the function is performed. Of the tasks listed, what percentage of time is devoted to each? The more time employees spend on a function, the more likely it is that the function is essential. Generally, include those functions that account for 10% or more of the work, i.e., key items that contribute significantly to the achievement of the job.  The functions should add up to 100%.

 

PERCENT OF TIME

(Time of all duties must add up to 100%)

FREQUENCY

(daily, weekly, monthly, quarterly, yearly)

ESSENTIAL DUTIES (List in order of importance – most significant first)

60%

Daily

To perform the packaging activities as per Production Batch Record.

30%

Daily

To perform Major and Minor cleaning and set up of the equipment according to Standard Operation Procedure (SOP) and room.

5%

Daily

To calibrate the balances and scales according to SOP's

5%

Daily

To keep the department neat and clean.

 
OTHER FUNCTIONS AND RESPONSIBILITIES

Other duties listed in this section are not essential or intrinsic to the job but are performed at times. Included in this section should be a general statement such as. “Perform other duties as assigned.” This phrase allows the supervisor to assign sporadic or one-time tasks as needed.

 

  • Perform any and all additional tasks relating to the operation of the manufacturing department as requested.
  • And perform other duties as assigned

QUALIFICATIONS

Work experience:  Prefer minimum one (1) year of work experience in a pharmaceutical or related manufacturing environment.

 Skills, knowledge and abilities:-  A demonstrated ability to follow written instructions precisely and perform basic math                                                                               calculations is required.

Should have an understanding/knowledge of cGMP, safety criteria or the ability to learn.      

 

 
REQUIRED

NA

 

ANY REQUIRED LICENSES/CERTIFICATIONS

Identify all licenses or certifications required by law or policy to perform the duties.

 

 

PHYSICAL REQUIREMENTS/WORK ENVIRONMENT

Attach Physical Requirements for Employment form which describes activities such as:  bending, lifting, walking, sitting, turning, repetitive motion, and environmental conditions to the extent that the physician performing the pre-employment physical examination (if required) can determine whether the person is physically fit to perform the duties without injuring themselves or others.  This form (see pages 3-4) also addresses exposure risks to the employee (i.e., blood, body fluids or tissues). Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.    Note: For most office positions, the statement “Work is primarily sedentary in nature, no special demands are required.” is sufficient.  This section need only be completed when the job has specific physical demands; otherwise it can be removed or worded in sentence format.

PHYSICAL REQUIREMENTS AND WORK ENVIRONMENT

1. Check the frequency and number of hours a day the worker is required to do the following specific types of activities:

ACTIVITY

FREQUENCY

# OF HOURS A DAY

 

CONTINUOUS

INTERMITTENT

1

2

3

4

5

6

7

8

8+

a. Sitting

 

 

 

 

 

 

 

 

 

 

 

b. Walking

 

X

 

 

 

 

 

 

 

X

 

c. Standing

X

 

 

 

 

 

 

 

 

X

 

d. Bending

 

X

 

X

 

 

 

 

 

 

 

e. Squatting

 

X

X

 

 

 

 

 

 

 

 

f. Climbing

 

X

X

 

 

 

 

 

 

 

 

g. Kneeling

 

 

 

 

 

 

 

 

 

 

 

h. Twisting

 

X

X

 

 

 

 

 

 

 

 

i. Lifting

 

X

X

 

 

 

 

 

 

 

 

 

LIFTING             

                          0-10 kgs.          10-15 kgss.              15-30 kgs.              Over 30 kgs.

2a. HAND MANIPULATION REQUIRED?                _X__Yes (If yes, complete a,b,c,d,e)        _____No

2b. Repetitive hand movements?            __X__Yes                                               _____No

2c. Simple Grasping?

Right Hand_X__

Yes__X__  No_____

Left Hand_X__ 

Yes___X__  No_____

2d. Power Grasping?

 

Right Hand_____

Yes__X_  No_____

Left Hand_____ 

Yes__X__  No_____

2e. Pushing Pulling?

Right Hand__X__

Yes_X___  No_____

Left Hand__X___ 

Yes______  No_____

2f. Fine manipulation:

Right Hand___X__

Yes__X___  No_____

Left Hand__X___ 

Yes__X____  No_____

3. (a) Does the job require worker to reach or work above the shoulder? __X___Yes    _____No    _____Frequency (Once in a while)

    (b) Reaching at or below shoulder level? _____Yes    _____No   _____Frequency (Once in a while)

 

4. Does the job require use of his/her feet to operate foot controls or       __X__Yes once in a while if required   _____No  

    for repetitive movement?

 

5. Are there special visual or auditory requirements?                              _____Yes    _____No

Describe:  Working with computer terminal Once in a while if required

 

WORK ENVIRONMENT:

  1. Does the employee work near moving mechanical parts; in high, precarious places; and in outside weather conditions?                                            __X___Yes                   ______No
  2. Is the employee exposed to fumes or airborne particles?     __X___ Yes  Employee must wear protective equipment as per SOP's.                   ______No

 

 

BLOOD/FLUID EXPOSURE RISK: (check the right category)  N/A

 

___NA____Category I:   Tasks involve exposure to blood, fluids or tissue

____NA___Category II:  Usual tasks do not involve exposure to blood, body fluid, or tissues but job may require performing unplanned Category I tasks.               

____NA___Category III: Tasks involve no exposure to blood, body fluids, or tissues. Category I tasks are not a condition of employment.

 

 

ACKNOWLEDGMENT:

I have developed and reviewed this Job Description for accuracy of the job functions:

 

___________________________________________________________

Hiring Manager / Supervisor’s SignatureDate

 

 

Post Date of Hire:

 

By signing below, I acknowledge that I have reviewed the above. I accept the responsibilities or the job description above.

 

Printed Name of Employee: ____________________________Date: ____________

 

Signature of Employee: _______________________________

----------------------------------------------------------------------------------------------------------------------------------------------------

 

Printed Name of Supervisor: ______________________________Date: _____________

 

Signature of Supervisor: __________________________________

 

Title: __________________________________________________

 

 

JD-MFG-PACKAGING-OPERATOR-02 Rev 07-05-2016

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