ResponsibilitiesThe QA for QC employee for Drug Product External Manufacturing (DPEM) provides quality laboratory oversight, assistance, and initial guidance to issues such as non-conformance investigations, change control proposals, method transfers, specification development and maintenance, validations, and other duties associated with daily laboratory activities occurring at our contract external manufacturing organizations (CMs). This role provides and assures compliance to established quality policies by resolving identified procedural gaps and works within the Lilly Joint Process Team (JPT) to assure the CM maintains a state of control with regards to laboratories. The QA for QC employee is integral for maintaining GMP compliance, providing support as applicable during preparations for pre-approval/general inspections by various agencies, and launching new products, processes, and CMs.
A specific focus for this role is Laboratory Primary Loop activities, which provides oversight, assistance, and guidance to CMs and other DPEM team members for lab activities.
Key Objectives/Deliverables:- Be the conduit. Build and maintain strong working relationships with key CM personnel in addition to partnering with the JPT to ensure the laboratory function at the CM operates with excellence and supports the operational control strategy. This requires routine face-to-face communications with both JPT and CM.
- Provide initial consultative guidance and quality oversight of laboratory issues, OOS investigations, deviations, change controls and counter measures to both Lilly JPT and the CM.
- Partner with the broader Lilly network to leverage depth of technical expertise at Lilly in order to resolve product related issues.
- Provide technical leadership and project management oversight to drive improvements to CM lab quality systems. Further support CMs efforts to maintain and improve their quality systems, including consulting with CM labs to understand Lilly laboratory quality requirements.
- Provide support to DPEM QA/QC Secondary Loop personnel to support commercial launch activities surrounding new products/ packages/ CMs.
- Some specific responsibilities which this role is responsible for owning, include:
- Input/verify CM laboratory data within supporting systems (e.g., DARWIN/LIMS) to create CoAs in support of batch release activities. Provide CoA support for both internal and external customers.
- Coordinate the supply of reference standards to CM labs, as applicable.
- Support/oversee implementation of analytical method and specification and change request for labs supporting final product release testing.
- Change control owner and execution for analytical/specification updates, protocol revisions, and continuous improvement projects within DPEM.
- Provide and coordinate designated sections including trend analysis of analytical data for Annual Reports and Annual Product Reviews.
- Own the DPEM stability program for your CM, ensuring all annual/validation stability commitments are met, up to and including active data trending of CM data.
- Review/approve laboratory GMP documents, including testing methods, procedures, change controls, method transfer/validation protocols, analytical standards, stability data, and associated reports to align with Quality Agreement requirements and drive improvements through the lens of aligning with Lilly quality standards, where possible.
- Execute SOP assessments of CMs and track completion of outstanding issues.
- Advise DPEM QA Management and JPT on technical laboratory issues.
- Support ongoing maintenance of analytical methods and specifications.
- Provide support on site or remotely before, during and after GQAAC audits.
Basic Qualifications- Bachelor's Degree in a science related field such as Engineering, Pharmacy, Chemistry, Biological Sciences or related Life Sciences or equivalent experience.
- At least 5 years Pharmaceutical Quality Control Experience.
- Experience with cGMPs and the Global Quality Standards.
- Experience with Pharmaceutical Manufacturing Operations.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Additional Skills/ Preferences- Experience in Lilly electronic quality systems preferred (Darwin/LIMS, GPCMS, CAPA, SAP, Trackwise).
- Technical knowledge of laboratory quality systems, methods, and equipment.
- Understanding of Micro/Sterility Testing in addition to chemical/analytical testing.
- Knowledge regarding Specification and Materials/Supplier Management.
- Demonstrated knowledge regarding product stability and program oversight.
- Demonstrated project management experience, leveraging tools to drive timelines.
- Coaching and mentoring skills, with demonstrated experience of delivering results through others.
- Demonstrated experience leveraging artificial intelligence (AI) solutions to drive continuous improvement
- Demonstrated experience working with third parties effectively and through ambiguity
- 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%.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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