Quality Control Laboratory Manager

  •  

Hicksville, NY

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 4 days ago

Job Summary

Title: Quality Control Laboratory Manager

Company: Pharmaceutical

Location: Long Island, NY

Type: Permanent Role

Notes: No Corp to Corp

Responsibilities:

  • The Laboratory Manager is a resource and go- to-person for other individuals for chemistry and activities associated with the function performed.
  • Primary responsibilities include leading, mentoring and developing the chemistry team which supports cGMP manufacturing facility. He/ She needs to be capable of making sound decisions to meet regulatory requirement of various agencies: FDA, EU, Health Canada along with production requirements. Have a good degree of initiative to resolve Laboratory problems, discuss and research action to be taken before finalizing a resolution.

Requirements:

  • Bachelor of Science degree required
  • Chemistry degree preferred
  • Five years' work experience in a regulated laboratory setting
  • Knowledge of cGMPs related to US FDA, Health Canada and EMEA manufacturing environments
  • Knowledge of Quality System requirements
  • Knowledge of ICH, USP, and EP requirements
  • Knowledge of laboratory instrumentation i.e. HPLC, UPLC, ICP-OES, ICP-MS, Dissolution, IR etc. and proprietary software
  • Manage daily activities and assist in overseeing timely testing of finished product, stability and validation samples in Quality Control Laboratory for over the counter (OTC) pharmaceutical products
  • Track testing samples to meet deadlines
  • Review sample requirements for stability and validation testing.

Next Steps: Send me a quick email if you are passively or actively looking for another opportunity. Love to speak with you.

Referral Bonus: As always, we will give you a $500 referral bonus if we place someone you refer over to us! Ask me for details.