Shire Jobs

GENERAL DESCRIPTION:

The QC Analyst I performs testing of samples submitted to the laboratory in a cGMP compliant manner, as well as according to approved written procedures.  The QC Analyst I may be required to write or revise SOPs, analytical procedures, or other analytical documentation at the discretion of quality control supervisory staff.

KEY DUTIES:

• Perform testing in accordance with written procedures (i.e. USP/EP/JP grade)
• Documentation of laboratory activities including worksheet/notebook entries according to procedures that define laboratory documentation practices.
• Processing of electronic data using procedures that ensure data integrity and security.
• Ship samples to contract testing facilities.
• Entry of test results from contract laboratories
• Review and countersign (when necessary) logbooks, notebooks, and worksheets for the purpose of verifying compliance with written procedures, good documentation practices, data integrity and accuracy of calculations.
• Transcribe results onto analysis reports.
• Perform daily standardization and performance verifications on laboratory equipment.
• Comply with site-wide procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety, and electronic data security.
• Identify deviations to written procedures.
• Disposal of laboratory waste on an as needed basis.
• Identify and report unsafe conditions within the laboratory.
• Identify OOS results, atypical results, and atypical laboratory events requiring a laboratory investigation; perform investigative testing. 

SKILLS/ABILITIES:

• Ability to perform routine analysis, such as wet chemistry and operate basic laboratory equipment.
• Understands paperwork review process. 
• Ability to follow written procedures and exhibit excellent documentation practices.
• Basic laboratory knowledge and skills
• analytical techniques in wet chemistry/chromatography
• Practical experience with various types of laboratory instrumentation
• Troubleshooting skills with analytical methodology and instrumentation.
• Technical writing skills
• Employee must be able to pass a vision exam prior to employment and annually thereafter. 

PERSONAL ATTRIBUTES:

• Proactively achieves results for the best of the organization.
• Willingness to learn new things.
• Ability to function in a small company atmosphere.
• Ability to cope with a rapidly changing work environment.
• Commitment to teamwork.
• Commitment to continuous improvement in all areas.
• Ability to focus attention to details and ensure high quality work.
• Ability to work safely; seek out and encourage safe practices
• Responsible for managing their time, organizing their workload to be efficient, and have good organizational and communication skills

EDUCATION AND EXPERIENCE:

• Bachelors Degree in Chemistry with 0-2 years of laboratory experience.  Other fields of specialty in Sciences are also acceptable provided sufficient chemistry coursework is completed.

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