Apex Life Sciences has an exciting opportunities for experienced Chemists to work for a Global Pharmaceutical company in South New Jersey. Ideal candidates will have 1-2 years' of analytical experience, but entry-level graduates will be considered.
The QC Chemist applies scientific principles to perform both routine and more complex analysis on raw material, in process, and final product samples in support of the business needs. The incumbent performs analytical work as directed by a QC Supervisor. The incumbent utilizes established instrumental procedures and/or analytical methods as provided from compendial sources, in-house testing monographs, and protocols. In addition, the incumbent should possess sufficient knowledge and experience to apply a technique within their area of expertise to new applications as required. In addition, the incumbent at this level should possess sufficient knowledge and experience to diagnose and solve method issues with minimal assistance from a senior analyst.
§ Analyze raw materials, intermediates, finished products, stability samples and any process related samples using approved methods and accepted laboratory practices. Document and report results in compliance with cGMP/ISO guidelines. Validate results from selected types of samples and tests (in process, cleaning, raw materials, equipment calibration)
§ Recommend/write method modifications in their area of expertise.
§ Monitor instrument performance and/or assay results and initiate/escalate method deviations and out-of-specification results as appropriate.
§ Participate in product transfer activities as needed.
§ Independently evaluate results from routine analysis and proactively identify potential problems.
- Make recommendations for method improvements and submit methods or modifications in writing for implementation.
§ Review and follow the current methods and procedures outlined in the United States Pharmacopeia (USP) as required. In addition, the incumbent should be able to interpret and execute methods given in the British, European, and Japanese Pharmacopeias.
- Investigates lab deviations and submits completed reports for review and approval.
- Participates in product team meetings as required to provide relevant quality control guidance to the team.
- Participates in lab investigations, report findings, and identify and initiative CAPA’s as required.
- May perform high level projects as required.
Are you the ideal candidate?
§ BS in Chemistry or related science
§ At least 1-2 years of analytical lab experience, including 1 year lab experience in a cGMP environment.
§ Proficient in investigative writing and root cause analysis.
§ Proficiency with wet chemistry techniques and gravimetric assays.
§ Proficiency with HPLC and GC testing techniques.
§ Proficiency with non-chromatographic instrumental analysis, such as UV, IR, KF, etc.
§ Proficiency with ICP/AA metal analysis.
§ Familiarity with mass spec. analysis
§ Ability to evaluate results from routine analysis and identify problems as they occur.
§ Proficiency in word processing, database, spreadsheet and electronic documentation software.
§ Complete familiarity with applicable Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMPs), and established company health and safety regulations
Please send all resumes to Teleca Ogele at [Click Here to Email Your Resumé] for consideration.
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.