Position Title: Chemist Analyst - Pharma Manufacturing : Summary: The Chemist Analyst in Pharma Manufacturing is responsible for performing analytical testing and quality control assessments of raw materials, intermediates, and finished pharmaceutical products to ensure compliance with regulatory standards and internal specifications. This role involves conducting a variety of chemical and physical tests, maintaining accurate records, and collaborating with other departments to support manufacturing processes. Responsibilities:
Conduct routine and non-routine analysis of raw materials, in-process samples, and finished products using analytical techniques such as HPLC, GC, UV-Vis spectroscopy, dissolution testing, titrations, and other applicable methods.
Perform physical testing including particle size analysis, viscosity measurements, and moisture content determination.
Ensure all testing procedures comply with established protocols, SOPs, compendial methods (USP, EP), and regulatory requirements (FDA, ICH).
Maintain and troubleshoot analytical instrumentation, ensuring equipment is calibrated and maintained in accordance with established procedures.
Document all analytical data accurately and completely in laboratory notebooks, electronic systems, and batch records.
Assist in method development, method validation, and stability studies as needed.
Investigate and resolve out-of-specification (OOS) results or deviations, participating in root cause analysis and corrective/preventive actions.
Support investigations related to product quality issues, deviations, and customer complaints.
Participate in internal and external audits, ensuring compliance with cGMP and company quality standards.
Collaborate with cross-functional teams including R&D, Quality Assurance, Manufacturing, and Regulatory Affairs to support product development, process improvements, and regulatory submissions.
Maintain a clean and safe work environment, following laboratory safety procedures and guidelines.
Stay current with industry trends, regulatory updates, and new analytical technologies through training, conferences, and literature review.
Qualifications:
Bachelor\xe2\x80\x99s or Master\xe2\x80\x99s degree in Chemistry, Pharmaceutical Sciences, or related field.
Minimum of 2 years of experience in a pharmaceutical manufacturing environment, preferably in a quality control or analytical laboratory role.
Strong knowledge of analytical techniques such as HPLC, GC, UV-Vis spectroscopy, and wet chemistry methods.
Familiarity with cGMP regulations, FDA guidelines, and pharmacopeial requirements.
Experience with analytical method validation, equipment qualification, and data integrity principles.
Excellent attention to detail, organizational skills, and ability to multitask in a fast-paced environment.
Strong communication skills, both written and verbal, with the ability to effectively collaborate with cross-functional teams.
Ability to work independently as well as part of a team, with a proactive and problem-solving mindset.
Proficiency in Microsoft Office Suite and experience with laboratory information management systems (LIMS) is a plus.
Flexibility to work occasional weekends or off-hours based on production needs or project requirements.