Chemist I

• SUMMARY OF POSITION**The Quality Control Chemist I:-
  
  

Performs routine testing to assess the conformance of raw materials, finished products, and/or stability samples to predetermined product specifications.-

Performs routine testing in conformance with approved procedures, accurately and concisely documents data, and reports results.-

Demonstrates a basic knowledge of SOP's and GMP regulations as related to the pharmaceutical quality control laboratory.**ORGANIZATION STRUCTURE**The Quality Control Chemist I / Microbiologist I reports into the Manager Quality Control or Team Leader Quality Control.**RESPONSIBILITIES**Primary responsibilities of this role include the following:-

• Safety**
• Perform job functions in a safe manner consistent with site safe practices and regulatory (e.g. - OSHA) requirements
• Participate in weekly/monthly safety training, identify potential safety hazards and cooperate with investigations of safety related incidents-
• Compliance**
• Conduct assigned tasks in compliance with cGXP requirements, current industry standards, compendia standards, FDA expectations and internal procedures
• Assist with laboratory investigations to ensure they are conducted in a timely manner and are completed within established target completion dates
• Maintain required level of training needed to perform a GMP task-
• Productivity**
• Perform routine sample analysis requiring general laboratory skills such as weighing, pipetting, titration, and basic operation of laboratory instrumentation
• Comprehend and follow approved test methods accurately in the performance of sample analysis to ensure adherence to "Right-the First Time" philosophy
• Perform analysis with a practical understanding of the test procedure and instrument operation
• Use available software to control instrumentation, collect data, process and calculate results, and report results
• Perform testing to evaluate physical characteristics of raw materials and finished products
• Work under direction provided by supervisor
• Calculate results and assess conformance with specifications
• Notify manager immediately of nonconforming data or unexpected occurrences
• Organize work schedule to complete assigned tasks efficiently and on schedule
• Maintain accurate record of analysis and perform documentation to company standards
• Prepare test solutions, reagents, and samples used in analysis
• Other duties as assigned**QUALIFICATIONS**
• BS in Chemistry, Biochemistry, Microbiology or Biology or related discipline2.
  
  

0-3 years experience in a pharmaceutical QC laboratory environment

• Understanding of cGXP requirements preferred
• Organization, communication and interpersonal skills**GMP DECISION-MAKING AUTHORITY**Responsible for decisions related to:
• When laboratory management must be notified to determine whether an investigation is warranted
• Maintain required level of training needed to perform a GMP task
• Suitability of analytical equipment/instruments for useThis role will offer a base salary that commensurate with experience and demonstrated skills at $62,354.00."**An Equal Opportunity Employer, including disability/vets."**EOE/M/F/Vet/Disability