QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated, and enthusiastic individual to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
- Ensures that chemistry laboratory operations are performed according to good laboratory practices delineated in GMPs, company standards, and regulatory requirements (FDA Guidelines for laboratory operations), and regulations applicable to countries where the product is marketed.
- Evaluates test results to ensure compliance with specifications, policies, procedures, and regulatory requirements. Evaluates trends and provides support and approves corrective and preventive actions to prevent recurrence. Leads and performs investigations of any out-of-specification results and system suitability in a timely manner. Completes risk assessments when applicable.
- Ensures and maintains product quality through compliance with QMS, meeting customer and corporate requirements.
- Ensures follow-up to internal supplier failures to assure compliance with GMPs and internal policies. Evaluates possible risk factors involved in the sampling and analysis of product and materials.
- Ensures that all analysts assigned to perform testing have been adequately trained in the tests and test methodology according to good laboratory practices delineated in GMPs, company standards, and regulatory requirements (FDA Guidelines for laboratory operations).
- Ensures timely completion of testing to support product releases by effectively coordinating testing activities. Exercises effective status communication to other functional groups that depend directly on laboratory results. Ensures the use of EMS tools to visualize improvement opportunities and provide support to cost reduction and continuous improvement projects.
- Ensures that laboratory documentation complies with good laboratory practices delineated in GMPs, company standards, and regulatory requirements (FDA Guidelines for laboratory operations).
- Responsible for maintaining all chemistry laboratory programs including reference standards, training documentation, laboratory calibrations, procedures, monographs, specifications, and laboratory housekeeping in compliance with internal and external regulations, EHS, quality agreements, and stability programs.
Qualifications:
- Bachelor's Degree or Master's Degree in Chemistry. Chemical License (preferably).
- Five (5) years of experience in a supervisory role, preferably in the pharmaceutical field, with a solid background and experience in chemical laboratory, project management, validations, and product transfer.
- Knowledge of cGMP, DEA, and other applicable regulations.
- Good interpersonal and troubleshooting skills.
- Critical thinking and analytical skills.
- Fully bilingual (English and Spanish).
- Knowledge in Microsoft Office System (Word, Excel, PowerPoint, etc.).
- Availability for 3rd shift.
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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