Zimmer GmbH
Lab Technical Sppt Partner
Zimmer GmbH - Ponce, Ponce, us, 00716
Work at Zimmer GmbH
Overview
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Overview
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. We focus on development opportunities, employee resource groups (ERGs), flexible working environments, competitive total rewards, wellness incentives, and a culture of recognition and performance awards. We are committed to creating an inclusive, respectful, empowering, and recognized environment for all team members.
What You Can Expect
Ensure compliance of tests conducted in laboratories for raw materials, components, and finished products. Have authority to block impacted products due to non-conformity or OOT/OOS results, and suspend production if necessary. How You'll Create Impact
Reporting to the Laboratory and Sterility Assurance Manager, your responsibilities will include: Verifying, analyzing, interpreting, and approving laboratory test results (Physicochemical, microbiology, mechanical tests, recipes) and certificates of analysis for raw materials and products, complying with current regulations and group specifications. Conducting and leading investigations for out-of-trend, out-of-specification results, or non-conformities related to laboratory activities. May lead multidisciplinary work groups. Managing activities for the laboratory sector and tracking change requests impacting laboratory operations. Defining qualification strategies for equipment and validation of analytical methods. Drafting, reviewing, and approving qualification/validation protocols and reports. Maintaining quality documentation for the Laboratory sector and coordinating updates. Drafting quality documents (procedures, instructions, forms, etc.). Monitoring regulatory and normative updates related to the role. Participating in drafting and reviewing industrialization documents (e.g., PFMEA, DMR, FCP). What Makes You Stand Out
You should have a degree of Bac +2 to Bac +5 in chemistry, analytical methods, or materials science. Knowledge of regulatory and normative frameworks: ISO 13485, 21 CFR 820 FDA, European regulations. Familiarity with Good Laboratory Practices / ISO 17025 and European and US Pharmacopoeias. Proficiency with quality tools: CAPA/IE, Non-Conformance, Change Management, OOS, Deviations. Travel Expectations
EOE/M/F/Vet/Disability
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Ensure compliance of tests conducted in laboratories for raw materials, components, and finished products. Have authority to block impacted products due to non-conformity or OOT/OOS results, and suspend production if necessary. How You'll Create Impact
Reporting to the Laboratory and Sterility Assurance Manager, your responsibilities will include: Verifying, analyzing, interpreting, and approving laboratory test results (Physicochemical, microbiology, mechanical tests, recipes) and certificates of analysis for raw materials and products, complying with current regulations and group specifications. Conducting and leading investigations for out-of-trend, out-of-specification results, or non-conformities related to laboratory activities. May lead multidisciplinary work groups. Managing activities for the laboratory sector and tracking change requests impacting laboratory operations. Defining qualification strategies for equipment and validation of analytical methods. Drafting, reviewing, and approving qualification/validation protocols and reports. Maintaining quality documentation for the Laboratory sector and coordinating updates. Drafting quality documents (procedures, instructions, forms, etc.). Monitoring regulatory and normative updates related to the role. Participating in drafting and reviewing industrialization documents (e.g., PFMEA, DMR, FCP). What Makes You Stand Out
You should have a degree of Bac +2 to Bac +5 in chemistry, analytical methods, or materials science. Knowledge of regulatory and normative frameworks: ISO 13485, 21 CFR 820 FDA, European regulations. Familiarity with Good Laboratory Practices / ISO 17025 and European and US Pharmacopoeias. Proficiency with quality tools: CAPA/IE, Non-Conformance, Change Management, OOS, Deviations. Travel Expectations
EOE/M/F/Vet/Disability
#J-18808-Ljbffr