Stability Coordinator - Quality

Totowa, NJ
Full Time
Entry Level
Title: Stability Coordinator 
Reports to: Manager, Quality Systems/ Validations 
Department: Quality 

Responsibilities: 
  • Reviews batch and finished product stability samples using approved stability protocol, current product specifications and sample submission forms.
  • Prepares stability samples and submission documents. 
  • Co-ordinates with testing labs as required.
  • Facilitates maintenance of awareness and compliance with cGMP and safety regulations in production, manufacturing and related areas.
  • Maintain current logs (with sent dates, result due dates, result receipt dates, etc) for all stability samples to support approved protocols.
  • Daily / Periodic monitoring and documentation of (a) Walk-in; (b) Reach-in; and (c) Freeze/Thaw chambers and their parameters such as temperature and humidity, PM, calibration, Water supply, etc.
  • Must be familiar and current with Englewood SOP 1-050 (Operating, Maintaining and Monitoring of Stability Chambers); SOP 1-033 (Stability Testing for Drug Products) and Englewood Lab Quality Form, EQF 206, 207, 022 and EQF 121.
  • Prepares stability sample submission documents to cover long term, accelerated, freeze-thaw, intermediate (if applicable), preservative challenge test (PET).
  • Maintains stability reports including compatibility, analytical method validation, and PET.
  • Assemble on-going, in-progress, and completed reports for review by QC Manager or designee.
  • Maintain tracking logs and correspondence to support stability sample submission to approved labs and for customer evaluation.
  • Immediately notify Quality personnel if out-of-specification (OOS) is observed in stability test results.
  • Periodically review stability logs for completeness.
  • Ensure that only most current versions of product specifications are used for product testing by the approved labs.
  • Ensure on-time submission of samples and receipt of results/customer approvals.
  • Maintains awareness and compliance with US FDA, ICH Stability, GMP and safety regulations in performing job duties.
Qualifications:
  • High School diploma or GED.
  • Two to five years experience in cosmetic, device, food or pharmaceutical inspection process.
  • Good math skills.
  • Ability to read and interpret internal and external sampling plans and effectively report results.
  • Effective communication skills with internal and external customers.
  • Ability to lift and carry up to 10-15 pounds. 

Compensation & Benefits: 

  • Pay range: $52,000 - $55,000 per year 
  • Medical, Dental, and Vision Insurance
  • Life Insurance
  • 401k match
  • PTO
Share

Apply for this position

Required*
Apply with Indeed
We've received your resume. Click here to update it.
Attach resume or Paste resume
Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

Invitation for Job Applicants to Self-Identify as a U.S. Veteran
  • A “disabled veteran” is one of the following:
    • a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or
    • a person who was discharged or released from active duty because of a service-connected disability.
  • A “recently separated veteran” means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
  • An “active duty wartime or campaign badge veteran” means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
  • An “Armed forces service medal veteran” means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
Veteran status


Voluntary Self-Identification of Disability
Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 04/30/2026
Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Please check one of the boxes below:

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

You must enter your name and date
Human Check*