QC Document Reviewer
Job Summary
Responsible for the document review of bulk and packaged products, raw materials and stabilities. The essential duties and responsibilities listed below are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities.
Essential Duties And Responsibilities
• This position is responsible for reviewing the basic and (complex) analytical documentation of drug product and drug substance testing performed by QC analysts in a timely and compliant manner, as instructed by QC Management, per PAI finished product and stability specifications and USP methodology to ensure finished goods are acceptable for distribution.
• Responsible for ensuring QC documentation of all analyses was performed per cGMP and FDA guidelines.
• Responsible for performing monthly reviews of QC logbooks to ensure all entries are cGMP compliant.
• Responsible for verifying entry of data into LIMS system.
• Review instrumentation and equipment calibrations on an as needed basis.
• Responsible for document review of routine laboratory functions to support manufacturing/production and assure that production schedule is met.
• Responsible for maintain clean or organized work space.
• Accountable for the accuracy and timeliness of work.
Reviewer II: Advise QC Chemists on documentation practices and corrections with management oversight.
• Reviewer II: Assist in writing and revising Raw Material Specifications and Finished Product and Stability Specifications to ensure cGMP compliance.
• Perform other duties as assigned.
Education And/Or Experience
This position requires a Bachelors’ degree in chemistry, biology or other science field. Plus 2 years of related experience and/or training. Working knowledge of Microsoft Office Suite is required. Chromatographic software such as OpenLab, Empower and LIMS software is preferred.
Knowledge, Skills & Abilities
This position requires the individual be organized, detail-oriented, and self-motivated and to apply advanced mathematical concepts and operations. The ability to apply principles of logical and scientific thinking to a wide range of intellectual and practical problems. Decision making, communication, planning and critical thinking skills are a must. Analytical ability / problem solving, along with accuracy is required.
Physical Requirements/Working Conditions
The physical requirements and working conditions listed for this job are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities. Computer keyboarding, computer monitor and mouse use including reaching forward, grasping, finger and wrist manipulations, and neck bending and turning: near vision is necessary for computer monitor use. Frequently required to stand, sit, walk, talk and hear, occasionally required to reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl. Occasionally lift up to 10lbs. This position may be occasionally exposed to toxic chemicals.
PAI is an Equal Opportunity Employer. PAI uses E-Verify.
EEO Employer / Veteran / Disabled.
Pharmaceutical Manufacturing
Legal
Full-time