QC Stability Associate


Melville, New York

10 days ago

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Job Description

Job title: QC Stability Associate
Duration: 7 months
Melville, NY 11747


The QC Stability/Lab Technician Associate is responsible for assisting with the company's stability program for commercial and post-approval change batches monitored on the stability program and to support the QC Laboratories with sample receipt/control and glassware maintenance.
1. For the stability department, this includes the performance of area responsibilities necessary to ensure that stability activities are in accordance to SOPs, cGMPs and FDA requirements and are consistent with company objectives.
2. This is not an exhaustive, comprehensive listing of job functions.
3. Stability Management, as required, may assign other activities in addition to the following.
  • Receive and store all stability samples in temperature controlled environment(s) in accordance with SOP and protocol requirements.
  • Coordinate sample pulls from protocol requirements, pull samples and submits to Quality Control Laboratory.
  • Prepare sample labels and aliquot stability samples.
  • Maintain the stability room in an organized manner and in compliance with cGMPs.
  • Set up stability studies and enter results into the stability system.
  • Maintain stability files in an organized manner for review.
  • Adhere to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, HS&E, and USP/NF etc.).
  • Ensure all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory standards, and Departmental, Plant, and Corporate quality and Safety goals.
  • Conducts self in a manner consistent with client Values and supports Quality Culture initiatives.
  • For the QC Laboratories, assist with Lab Technician responsibilities. Maintain established inventory list of chemicals and other laboratory items.
  • Receives newly purchased items and distributes to analysts. Restock as required.
  • Collection of used glassware from designated laboratory locations, cleaning of glassware using a dishwasher or by hand when necessary, restocking of clean glassware in specified areas.
  • Checks receipt of laboratory samples for accuracy, documents receipt of samples in appropriate logbook and returns sample submission sheets to initiating department, manual entry into logbook and LIMS entry.
  • The employee is frequently required to sit while performing the duties of the job.
  • The employee is occasionally required to stand, walk, and reach with hands and arms as well as being able to lift up to 50 pounds.
  • 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.

Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained under OSHA's HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander. In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.

All employees that have received the above mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA.

  • Pharmaceutical manufacturing and/or Quality Assurance monitoring experience highly preferred.
  • Knowledge of cGMPs and the ability to follow SOPs.
  • Associate's Degree or equivalent experience in lieu of a degree.

Perform other duties as required.

Good English written and oral communications skills required
Strong organizational skills / attention to detail required
Basic mathematical skills required
Working knowledge of Microsoft Word, Excel; Proficiency with computer applications
Ability to multi task and adapt to changing priorities
Ability to work in a team-oriented environment as well as being able to work independently 

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $28.00/hr.