Indiana Staffing
Sr. Associate - Quality Assurance Batch Release - Drug Product External Manufact
Indiana Staffing, Indianapolis, Indiana, us, 46262
Quality Assurance Associate for Batch Release
At Lilly, we unite caring with discovery to make life better for people around the world. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Drug Product External Manufacturing US (DPEM) Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight of North American contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination. DPEM Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers. Responsibilities
The QA Associate for Batch Release is responsible for final disposition of manufactured and packaged drug product batches. This role ensures that all batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements. Complete batch record and media fill reviews, reporting any issues Determine final disposition of batches by reviewing all required documentation, including but not limited to, change controls and deviations Originate and investigate deviations associated with batch records/release processes Work cross-functionally with Lilly support groups to resolve product-related issues Participate in the creation and revision of standard operating procedures, Master Batch Records and Master Packaging Orders Create Certificates of Analysis or other similar documentation for internal and external customers Review and approve documentation that supports manufacturing (e.g., deviations, changes, procedures, protocols), as applicable. Assist in the establishment and revisions of Quality Agreements with affiliates and customers as needed. Provide support to ensure on time completion of Annual Product Reviews Provide support to launch new products/packages/contract manufacturers (CMs) Participate on Joint Process Teams Maintain material management (e.g. check all API restrictions in SAP and apply those restrictions as required) Provide support for Notification to Management data gathering Provide input for metrics reports to management Complete process/productivity improvements and compliance projects as assigned Oversee the batch release qualification process, benchmark with internal organizations, and implement improvements Contribute to Quality culture efforts at both DPEM and CMs Complete other duties as assigned Recommend, support and drive cross-functional and interdepartmental continuous improvement efforts Basic Requirements
Bachelor's Degree in a science related field such as Engineering, Pharmacy, Chemistry, Biological Sciences or related Life Sciences 3+ years of experience in regulated manufacturing industry and/or quality experience; direct parenteral, device assembly, or final packaging experience preferred Additional Skills/Preferences
Proven ability to work independently or as part of a team to problem solve Experience with Pharma industry electronic systems (SAP, Trackwise, QualityDocs (Veeva)) Previous experience with batch disposition for drug product manufacturing and packaging processes Technical understanding of cGMPs and Global Quality Standards/Quality Systems Knowledge of Pharmaceutical Manufacturing Operations Strong written and verbal communication skills Teamwork and interpersonal skills exhibited across functional areas Ability to organize, prioritize, multi-task, and influence diverse groups Strong decision making and problem-solving skills Additional Information
Shift is days, but off-hours may be necessary to support operations Travel is possible, up to 10% This position is an onsite position that requires you to be onsite four days per week. This is not a remote position. Position is based out of Indianapolis, IN at Lilly Corporate Center. (relocation offered) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
At Lilly, we unite caring with discovery to make life better for people around the world. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Drug Product External Manufacturing US (DPEM) Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight of North American contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination. DPEM Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers. Responsibilities
The QA Associate for Batch Release is responsible for final disposition of manufactured and packaged drug product batches. This role ensures that all batches meet specifications, are manufactured/packaged in accordance with validated processes and are compliant with cGMP requirements and regulatory requirements. Complete batch record and media fill reviews, reporting any issues Determine final disposition of batches by reviewing all required documentation, including but not limited to, change controls and deviations Originate and investigate deviations associated with batch records/release processes Work cross-functionally with Lilly support groups to resolve product-related issues Participate in the creation and revision of standard operating procedures, Master Batch Records and Master Packaging Orders Create Certificates of Analysis or other similar documentation for internal and external customers Review and approve documentation that supports manufacturing (e.g., deviations, changes, procedures, protocols), as applicable. Assist in the establishment and revisions of Quality Agreements with affiliates and customers as needed. Provide support to ensure on time completion of Annual Product Reviews Provide support to launch new products/packages/contract manufacturers (CMs) Participate on Joint Process Teams Maintain material management (e.g. check all API restrictions in SAP and apply those restrictions as required) Provide support for Notification to Management data gathering Provide input for metrics reports to management Complete process/productivity improvements and compliance projects as assigned Oversee the batch release qualification process, benchmark with internal organizations, and implement improvements Contribute to Quality culture efforts at both DPEM and CMs Complete other duties as assigned Recommend, support and drive cross-functional and interdepartmental continuous improvement efforts Basic Requirements
Bachelor's Degree in a science related field such as Engineering, Pharmacy, Chemistry, Biological Sciences or related Life Sciences 3+ years of experience in regulated manufacturing industry and/or quality experience; direct parenteral, device assembly, or final packaging experience preferred Additional Skills/Preferences
Proven ability to work independently or as part of a team to problem solve Experience with Pharma industry electronic systems (SAP, Trackwise, QualityDocs (Veeva)) Previous experience with batch disposition for drug product manufacturing and packaging processes Technical understanding of cGMPs and Global Quality Standards/Quality Systems Knowledge of Pharmaceutical Manufacturing Operations Strong written and verbal communication skills Teamwork and interpersonal skills exhibited across functional areas Ability to organize, prioritize, multi-task, and influence diverse groups Strong decision making and problem-solving skills Additional Information
Shift is days, but off-hours may be necessary to support operations Travel is possible, up to 10% This position is an onsite position that requires you to be onsite four days per week. This is not a remote position. Position is based out of Indianapolis, IN at Lilly Corporate Center. (relocation offered) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.