QA Dry External Intermediates Manufacturing Associate - Indianapolis
1 day ago
Job summary
The Dry EM Quality Assurance Representative provides support to all quality activities at Contract Manufacturing organizations (CMs) related to the manufacturing process of intermediates such as spry dry dispersion (SDD). The QA Representative position is essential for ensuring that all batches meet specifications are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments. Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations changes batch documentation that demonstrates requirements have been met prior to batch release.The job involves providing quality oversight of CMs including being the initial point of contact for all quality-related issues. Assist in the establishment and revisions of Quality Agreements with affiliates and customers. Coordinate perform QA responsibilities API shipments Participate on-site support during inspections Evaluate disposition batches intermediate if required. Provide holistic review key activities associated or impacting manufacturing processes including deviations change controls countermeasures Assess impact deviation investigations ensure appropriate records documented retrievable Maintain awareness external regulatory agency findings reference product Review approve documents procedures master production records change control proposals equipment qualifications analytical methods computerized system validations Participate APR projects improve productivity Joint Process JPT Post Launch Optimization PLOT Teams Basic Requirements BS science-related field Pharmacy Chemistry Biological Sciences Life Sciences GMP manufacturing knowledge experience API intermediates finished product manufacturing QC QA Engineering Qualified applicants authorized work United States full-time basis Lilly provide support sponsor work authorization visas role F-1 CPT F-1 OPT F-1 STEM OPT J-1 H-1B TN O-1 E-3 H-B11 L Additional Preferences Experience quality support Quality Control thorough technical understanding systems requirements Knowledge pharmaceutical operations Demonstrated coaching mentoring skills Experience root cause analysis demonstrated statistical skills strong written verbal communications Strong attention detail Proficiency computer system applications Excellent interpersonal networking Ability organize prioritize tasks influence groups manage relationships Additional Information Must complete training Dry EM Quality Assurance No certifications required Must able support hour/day operations Willingness travel expected % travelling Lilly dedicated helping individuals disabilities engage workforce ensuring equal opportunities vying positions If require accommodation submit resume position Lilly please complete accommodation request form further assistance Please note this individuals request accommodation application process correspondence will not receive response Lilly proud be EEO Employer does discriminate age race color religion gender identity sex gender expression sexual orientation genetic information ancestry national origin protected veteran status disability legally protected status Our employee resource groups ERGs offer strong networks members open employees Africa Middle East Central Asia Network Black Employees Lilly Chinese Culture Network Japanese International Leadership Network JILN Lilly India Network Organization Latinx at Lilly OLA PRIDE LGBTQ Allies Veterans Leadership Network VLN Women Initiative Leading at WILL enAble people disabilities Learn more our groups Actual compensation depend candidate education experience skills geographic location anticipated wage < $65,
$169,
,
Lilly offers comprehensive benefit program eligible employees eligibility participate company-sponsored benefits vacation flexible healthcare dependent daycare life insurance death benefits certain time off leave absence well-being employee assistance fitness clubs activities reserves right amend modify terminate its practices guidelines apply regarding details promotion transfer employees #WeAreLilly
Job description
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