Maintain and Monitor Environmental Storage Areas (ESA) in accordance with Regulatory Commitments. Provide maintenance and customer support for the LIMS Stability/Reserve Management. Review documentation required for sample studies and draft departmental policies and procedures.
Diploma Degree (science) and 3 years’ experience and/or Tech or Assoc degree and 5 years of Pharm. Experience and/or High School Diploma degree and 7 years of industry experience.
Knowledge of cGMP, FDA/CFR21 regulatory guidance regarding storage chambers and stability studies is required.
Previous experience in Laboratory setting is required.
Ability to completing advanced troubleshooting of analytical problems.
Demonstrated ability to follow procedures and maintain performance standards to support company goals and compliance with SOPs, cGMPs, GLPs, ICH, OSHA and USP.
Must possess good written and oral communication skills to communicate clearly and concisely; knowledge of structure and content of the English language (the meaning and spelling of words, rules of composition, and grammar), the ability to read and understand information and ideas presented in writing and through spoken words and sentences, the ability to enter, transcribe, record, store, or maintain information in written or electronic form.
Demonstrated teamwork skills - providing information and assistance to supervisors and co-workers in a collaborative manner which encourages trust, mutual respect, and shared purpose among team members.
Ability to be exact or highly accurate with attention to detail in performing duties.
Strong planning and organizing skills to ensure commitments and deadlines are met
Proficient experience with LIMS, QSDB, SAP, MS Word, Excel, Outlook, and/or PowerPoint required.