Job Description
Duties and Responsibilities:
- Testing experience: IR, pH, TLC-plates, Solubility, other wet chemistry analysis.
- Instrument experience: HPLC.
- Complete a peer review of analytical data.
- Draft/Execute Validation Protocols.
- Write Reports for executed Protocols.
- Act as technical review for Protocols and Reports.
- Proficient in following Compendial testing methods (USP/EP/JP).
- Utilize written procedures to perform testing.
- Demonstrate strong planning & organizational skills.
- Solution focused when faced with any problems or setbacks.
- Highly self-motivated.
- Strong initiative and drive.
- Demonstrated critical thinking skills.
- Demonstrate the ability to manage larger projects/process with minimal oversight.
- Utilize written procedures to perform testing.
- 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.
- Perform needed instrument or titrant verification/calibration during scheduled time.
- Demonstrates Good Documentation Practices (GDP) and Data Integrity Principles.
- Pays attention to detail and brings issues to supervision’s attention.
- Demonstrated ability to work effectively in a team environment.
- Knowledge of basic computer software (Microsoft Office and Microsoft 365).
- Demonstrate the ability to work independently and take initiative to perform daily job functions along with special projects.
- Work in accordance with current procedures and demonstrate proper laboratory safety and housekeeping practices.
Additional Responsibilities:
- Demonstrates our Core Values – Courage, Respect, Achievement, Integrity, Responsibility, Transparency.
- Follows all policies and procedures as defined from Corporate and Site.
- Develops and/or assist in the implementation of process improvement, safety, quality, and 5S ideas.
- Organizes and maintains a clean and orderly work area in accordance with the administrative General Housekeeping policy/procedures.
- Performs all functions in a safe and timely manner in accordance with OSHA standards and general rules and regulations governing the workplace.
- Responsible for following general personal protective equipment (PPE) requirements as established by company policy.
- Demonstrates professional working behavior when working with all staff and visitors.
- Follow trained requirement to IPEC cGMP/ISO9001/14001/45001 Management Systems, if appropriate.
- Seeks guidance from Supervisor as needed to ensure the above
Education & Experience:
- Bachelors’ degree in Chemistry or Life Science field with a Minimum 5 years of laboratory experience.
- Associate degree in Chemistry or other Life Science field with a Minimum of 10 years of experience outside of academic laboratories.
- Method Validation.
- Compendial Testing (USP/EP/JP).
- GMP laboratory.
Employment Testing Requirements:
- Pre/Annual-employment screening/medical monitoring.
- Pass background check, drug/alcohol screen.
Physical Requirements:
- The ability to stand for long periods of time.
- The ability to lift 25 lbs.