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Chemist II
2 months ago
We are seeking a skilled Chemist II to join our Quality Control laboratory team. In this role, you will conduct chemical analyses of raw materials, in-process materials, stability, and finished products, as well as support process validation testing.
You will be responsible for detecting and participating in investigations related to Out-of-Specification (OOS), Out-of-Trend (OOT), and other anomalies.
Key Responsibilities:- Analysis & Testing (65%): Conduct laboratory analyses including finished product, stability, raw material, cleaning verification, and manufacturing in-process testing. Activities include buffer/solution preparation, standard preparation, and operating analytical instruments such as HPLC, UV-Vis, FT-IR, GC, and others.
- Lab Equipment (20%): Provide general support for laboratory equipment, including routine cleaning, preventative maintenance, calibration, and sample handling. Maintain chemical inventory and ensure proper disposal of waste.
- Investigations (10%): Participate in investigations related to OOS, OOT, and other anomalies with guidance. Report questionable results to the Supervisor and recommend actions.
- Training (5%): Maintain up-to-date training records and assist in training less senior staff in documentation practices, lab skills, and chemical methodologies.
- Compliance (Continuous): Ensure all work is performed in accordance with regulatory, company, and compendial requirements. Document data accurately and follow internal processes related to controlled substances.
- Safety (Continuous): Adhere to EH&S procedures to ensure a safe working environment. Follow all safety guidelines, including SOPs, cGMP, DEA regulations, and MSDS.
- Education & Experience: Bachelors degree in Chemistry, Chemical Engineering, or a related field with at least 2 years of relevant analytical laboratory experience, or a Masters degree with at least 1 year of relevant experience preferred.
- Knowledge: Proficiency with laboratory techniques and instruments (e.g., HPLC, UV-Vis, FT-IR, GC). Working knowledge of safety and standards guidelines such as SOPs, cGMP, GLP, and DEA regulations. Competence in laboratory and chromatographic software (e.g., Waters Empower, Agilent ChemStation, Sotax WinSotax) and Microsoft Office Suite.
- Skills & Abilities: Strong analytical skills with the ability to present data logically. Excellent verbal and written communication skills, attention to detail, and accurate record-keeping. Ability to train and mentor less senior staff, take initiative, and manage priorities effectively.
