Analyst Jobs

About The Position

Requirements

• Bachelor’s degree in biology, microbiology, or other related field, or 1 year relevant experience in cGMP environment
• Must be capable of wearing all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles)
• Must be able to follow gowning/garbing procedures (cannot wear makeup, must remove jewelry before sterile compounding)
• Must learn and understand 21 CFR Part 210 and Part 211, along with other relevant cGMP regulations
• Must be capable of working with small, delicate pieces of machinery to complete appropriate dosage forms in a timely manner
• Must possess strong verbal, written, and oral communication skills
• Must be able to work independently and with a team
• Must possess problem-solving skills
• Ability to recognize priorities and take action; make productive use of time
• Must exhibit punctuality and low absenteeism
• Able to sit and/or stand 8-10 hours or more per day as needed
• Must be able to read, write, speak and understand English fluently
• Ability to read and interpret documents such as operating and maintenance instructions and procedure manuals
• Uses addition, subtraction, multiplication and the division of numbers including decimals and fractions when checking of reports, forms, records and comparable data where interpretation is required involving basic skills knowledge.
• Must have the ability to solve practical problems and deal with a variety of concrete variables in situations where substantial standardization exists.
• Must be able to interpret instructions furnished in written, oral, and diagram or schedule form.

Responsibilities

• Learn aseptic gowning and technique within a cleanroom environment
• Learn and apply GxP (GMP, GDP, GLP) to operations
• Perform viable/non-viable environmental monitoring and read/review microbial samples
• Assist in the media-fill process validations and inspection of filled units
• Perform document review of operation activities such as cleaning record, line clearance forms, and inventory/equipment checklist
• Document non-compliance and work with supervisor/lead if further investigation is needed
• Review production batch records and associated data for product release; determine if records are within cGMP regulations; review data obtained for compliance specifications and report abnormalities
• Perform audits on aseptic technique and operation documentation
• Ensure completeness and accuracy of information contained in all documents, document files, databases, and documentation systems
• Ensure timely assessment and closure of Change Controls
• Assist with equipment calibration program and maintenance record files
• Identify and assess quality risk in activities and processes according to regulatory guidelines and Standard Operating Procedures
• Assist in the training of new employees and other technical personnel

Benefits

• medical, dental and vision coverage
• life insurance
• Health Reimbursement Account
• Flexible Spending Account
• 401(K) retirement savings plan with a generous employer match
• bonus program
• paid holidays
• vacation and personal time