Med-Pharmex, Inc. is seeking experienced chemists to join our Quality Control team. The Chemistry Analyst performs testing and solution preparations, performs equipment & instrumental calibrations and maintenance, communicates between departments when reporting results, and executes test protocols as assigned by management. The analyst is also responsible for assisting in writing protocols & reports, as well as sampling raw material, finished goods, stability samples and additional samples as assigned.
Responsibilities include but are not limited to:
- Performs testing on raw material, in-process, & finished good samples.
- Prepares all solutions needed for testing.
- Performs testing on stabilities.
- Samples raw material, finished goods, stability samples and additional samples as assigned.
- Performs instrument & equipment calibrations/performance checks
- Documents all data in corresponding laboratory notebook
- Disposes of all chemicals safely
- Performs required testing pertaining to customer complaints, discrepancies, & laboratory investigations.
- Reports necessary results to production supervisors, in a timely manner
- Reviews laboratory SOPs
- Assists in the performance of qualifications and validations of instruments and test methods
- Performs impurity, supplier approval, and research testing
- Troubleshoots and maintains basic instruments
- Executes test protocols, as assigned by management
- Assists in writing protocols and reports
- Trains new employees in basic laboratory skills and functions
- Perform other duties as required to fulfill department and business needs.
- BS / MS in Chemistry, Biochemistry or related discipline is preferred.
- At least 1 years’ experience in a pharmaceutical industry required.
- Familiarity with Good Manufacturing Practices (cGMP’s) and Good Laboratory Practices (GLP) a must!
- Expertise in OOS/OOT/Atypical resolution, deviations, change controls, root cause analysis, and monitoring CAPA effectiveness would be a desirable.
- Experience with an ICH compliant stability program with the ability to perform statistical analysis to identify trends.
- Experience with electronic systems such as LIMS is an advantage.
- Knowledge of relevant FDA guidance documents.
- Preferable to have some experience in pharmaceutical industry Quality Control environment supporting US FDA pharmaceutical products.
- Possess an understanding of cGMP/compliance requirements for pharmaceutical products ideal.
- Ability to work independently with minimum guidance.
- Excellent verbal and written communication skills.
Position Type/Expected Hours of Work:
This is a full-time on-site position, and hours of business operations are Monday through Friday, 8:30 a.m. to 5 p.m. Must be available to work extended hours as needed to meet deadlines, including weekends from time to time.
Med-Pharmex is an Equal Opportunity Employer. The policy Med-Pharmex is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual’s age, race, color, sex, religion, national origin, disability, protected veteran status, sexual orientation, genetic information, or any other protected category recognized by state and federal laws.