IPQA Associate 2nd Shift


Job ID 17-00289

Industry Pharma

Job Type Permanent

Location Dayton, NJ

Description

JOB SUMMARY
IPQA Associate is to perform all required in- process testing & sampling for Manufacturing and Packaging batches. Perform incoming inspections and outgoing inspections of finished product batches. Perform verifications using special instruments (Caliper, Balance, etc.) to assign final Approval to Labeling, Packaging and Raw Materials.

REPORTING RELATIONSHIPS
This position reports to the QA Supervisor or QA Manager

DUTIES & ESSENTIAL JOB FUNCTINS
PERCENT OF TIME
(Time of all duties must add up to 100%)
FREQUENCY ESSENTIAL DUTIES (List in order of importance most significant first)
85 % Daily
  • Perform all required in-process testing & sampling of batches in progress and products to be packaged.
  • Perform line clearances of the manufacturing/ packaging areas and equipment
  • Verify and confirm issuances and reconciliation of product and components.
  • Performing Cleaning Verification/Validation Swabbing of Equipment
  • Verify that temperature/humidity, D.I. Water and Magnehelics are all in range/good working condition
5% Weekly
  • Handle various requests from departments for developmental or investigative reasons
  • Capture critical information for Customer Complaint/Deviation investigations/ CAPA (when necessary)
  • Review and Approve Preventive Maintenance or Work Orders; (if necessary)
  • Participate in Stability/Validation product Sampling
10% Monthly
  • Training of personnel on all pertinent documents and procedures, (including but not limited to their corresponding syllabus) as well as preparing them to become trainers themselves.
  • Complete all applicable training forms in a timely manner and forward to document control for archival
  • Data Entry of Finished Product Information into the APR (Annual Product Review ) system


NOTE: The duties in general include but are not limited to the above job functions and may change at the discretion of the QA Management.

OTHER FUNCTIONS AND RESPONSIBILITIES

  • Collection and inventorying of Retain and/ or Stability Samples
  • Maintaining various logbooks to document the performance or completion of specific functions (ex. Material Receiving Log)
  • Replace Temperature/Humidity Charts weekly
  • Maintaining IPQA supply inventory

 



Qualifications

QUALIFICATIONS

  • HS Diploma
  • Experienced in proper documentation and correction practices
  • Read, write and speak English

REQUIRED

  • 2-3 year experience performing in-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment.
  • Must be a Team player able to effectively communicate with QA Supervisor, IPQA, Quality Control, Production, and Supply Chain to meet finished product release goals
  • Be able to work long hours to support production requirements
  • Be available for overtime, including weekends, as needed for production support
  • Possess the ability to analyze information and make consistently good decisions

ANY REQUIRED LICENSES/CERTIFICATIONS

  • A familiarity with cGMPS, CFRs, OSHA and FDA regulations
  • Experience with deviations /incidents and CAPA

PHYSICAL REQUIREMENTS/WORK ENVIRONMENT

  • Stand/walk for the majority of the shift.
  • Must be able to bend at the waist and knees as well as twist at the trunk.
  • Must practice good personal hygiene
  • Must be able to lift up to 30 lbs.
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   X                  
b. Walking   X                  
c. Standing X               X    
d. Bending   X                  
e. Squatting   X                  
f. Climbing   X                  
g. Kneeling   X                  
h. Twisting   X                  
i. Lifting   X                  

LIFTING x
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_____
Yes_X____ No_____
Left Hand_____
Yes___X__ No_____
2d. Power Grasping? Right Hand_____
Yes_____ No__X___
Left Hand_____
Yes______ No___X__
2e. Pushing Pulling? Right Hand_____
Yes___X__ No_____
Left Hand_____
Yes___X___ No_____
2f. Fine manipulation: Right Hand_____
Yes__X___ No_____
Left Hand_____
Yes____X__ No_____
3. (a) Does the job require worker to reach or work above the shoulder? ___X__Yes _____No _____Frequency
(b) Reaching at or below shoulder level? ___X__Yes _____No _____Frequency (ONCE IN A WHILE)
4. Does the job require use of his/her feet to operate foot controls or _____Yes ____X_No
for repetitive movement?
5. Are there special visual or auditory requirements? __X___Yes _____No
Describe: Use of safety goggles/glasses, magnifier
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 ______No
BLOOD/FLUID EXPOSURE RISK: (check the right category) N/A

_______Category I: Tasks involve exposure to blood, fluids or tissue
_______Category II: Usual tasks do not involve exposure to blood, body fluid, or tissues but job may require performing unplanned Category I tasks.
_______Category III: Tasks involve no exposure to blood, body fluids, or tissues. Category I tasks are not a condition of employment.