Essential Job Functions and Responsibilities:
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Testing experience: IR, pH, TLC-plates, Solubility, other wet chemistry analysis
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Instrument experience: HPLC
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Complete a peer review of analytical data
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Draft/Execute Validation Protocols
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Write Reports for executed Protocols
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Act as technical review for Protocols and Reports
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Proficient in following Compendial testing methods (USP/EP/JP)
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Utilize written procedures to perform testing.
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Demonstrate strong planning & organizational skills.
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Solution focused when faced with any problems or setbacks.
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Highly self-motivated.
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Strong initiative and drive.
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Demonstrated critical thinking skills.
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Demonstrate the ability to manage larger projects/process with minimal oversight.
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Utilize written procedures to perform testing.
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Able to recognize out-of-spec (OOS) results and work through an investigation with minimal guidance to determine root cause with appropriate corrective actions, where applicable to QC.
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Perform needed instrument or titrant verification/calibration during scheduled time.
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Demonstrates Good Documentation Practices (GDP) and Data Integrity Principles.
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Pays attention to detail and brings issues to supervision’s attention.
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Demonstrated ability to work effectively in a team environment.
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Knowledge of basic computer software (Microsoft Office and Microsoft 365).
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Demonstrate the ability to work independently and take initiative to perform daily job functions along with special projects.
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Work in accordance with current procedures and demonstrate proper laboratory safety and housekeeping practices.
Additional Responsibilities:
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Demonstrates our Core Values – Courage, Respect, Achievement, Integrity, Responsibility, Transparency.
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Follows all policies and procedures as defined from Corporate and Site.
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Develops and/or assist in the implementation of process improvement, safety, quality, and 5S ideas.
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Organizes and maintains a clean and orderly work area in accordance with the administrative General Housekeeping policy/procedures.
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Performs all functions in a safe and timely manner in accordance with OSHA standards and general rules and regulations governing the workplace.
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Responsible for following general personal protective equipment (PPE) requirements as established by company policy.
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Demonstrates professional working behavior when working with all staff and visitors.
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Follow trained requirement to IPEC cGMP/ISO9001/14001/45001 Management Systems, if appropriate.
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Seeks guidance from Supervisor as needed to ensure the above
Education, Qualifications, Experience:
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Bachelors’ degree in Chemistry or Life Science field with a Minimum 5 years of laboratory experience
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Associate degree in Chemistry or other Life Science field with a Minimum of 10 years of experience outside of academic laboratories.
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Method Validation
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Compendial Testing (USP/EP/JP)
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GMP laboratory