Sr. Specialist, Quality Control

Job description

Job Description Position Overview - Basic Functions & Responsibility Essential function(s) includes, but is not limited to: Responsibility for daily operation of cells including coordination of testing and data review to meet due dates, and coordination of Quality Notifications. Drives continuous improvements, lean activities, kaizens and KATA methodology. Performs Quality sampling, testing, and release for bulk raw materials, active pharmaceutical ingredients, water, microbiological limits, primary packaging components and finished pharmaceutical products. Primary Activities Primary activities include, but are not limited to: · Drives continuous improvement and supports sustainability of implemented changes identified through such lean tools as Kaizens and / or champions new actions as a result of data obtained through lean six sigma tools such as KATA methodology. · Drives Deviation Reduction through trending and proactive identification of improvement initiatives. Mentors others to ensure right first time performance. · Leads Tier I Activities and actively participates in Tier II and Tier III when needed. · Demonstrated Subject Matter Expert for knowledge transfer of laboratory SOPs, product performance and method expertise. · Provides an environment conducive with the 12 Inclusive Behaviors, actively promotes inclusion and leads by example. · Leads the management of the investigation program, ensuring on time completion of investigations and ensures robust root cause and corrective actions are identified. Evaluates trends in performance and identifies and implements changes to drive reduction and prevention of deviation occurrences. · Leads the completion of responses and remediation for monthly walk thru audits. Drives proactive actions to ensure compliance of laboratory operation. · With expert knowledge of laboratory instrumentation and methodology, provides direction and training to laboratory resources. Monitors equipment availability and ensures minimization of laboratory equipment downtime. Works cross functionally for prioritization of laboratory equipment and offsite resources, when needed. · Maintains compliance by following corporate policies/guidelines and local SOP’s. Serves as mentor/trainer to others to ensure understanding and adherence to regulatory expectations. · Ensures optimal daily operation of the laboratory, including such activities as level loading of testing workload and the identification of activities to remediate unplanned deviations which impact testing regimes. · Tests and interprets results for raw materials, active pharmaceutical ingredients, water, microbial limit testing, finished pharmaceutical products, and stability samples. · Manages profit plan/budget activities to ensure efficient operation of the laboratory and drive improvement opportunities. · Interprets compendial and internal monographs, NDAs and our company's Quality Standards. · Provides technical and analytical support for cleaning validations, laboratory support requests, equipment validations, method transfers, and API Stability Packaging Description (ASPD). · Has deep understanding of cGMP, CFR and other agency regulations in order to assure laboratory compliance. Able to evaluate laboratory SOPs and recommend improvement opportunities to maintain compliance with corporate and regulatory guidelines. Develops or revises laboratory SOPs as required. · Leads promotion of safety, 5S and other local and corporate initiatives. Skills Requires expertise in the Quality Control Laboratory discipline and applies knowledge of internal/external business challenges to improve products and processes. Works independently with minimal guidance. Acts as a resource for colleagues with less experience within own discipline. Solves complex problems and takes a new perspective using existing solutions. Builds knowledge of the company, processes, and customers. May act as a team or project lead and leads work of others as required. Promotes teamwork and open discussion of issues while coaching and guiding others. Carefully weighs priorities, costs, and benefits when determining risks. Drives the use of team effectiveness skills, listening and integrating perspectives from across the work group while contributing and adding value to the achievement of team goals. Demonstrates a deep understanding of customer needs, requirements, and expectations and is sought out by peers as the expert. Consistently takes the customer point of view when examining implications of systems, process or workflow changes. Challenges the status quo and pushes others forward constructively. Responds to challenges non-defensively, effectively balancing one’s point of view with new information new information. Does not hesitate to deal with difficult conflict among peers and/or team members. Relentlessly pursues new opportunities to learn new skills and abilities and acquire new knowledge. Pays close attention to the work of others and proactively steps in to help as needed. Assists other team members, including helping with developmental activities. Demonstrates routine use of analytical tools to solve issues and simplify processes. Demonstrates capability as a visionary for on-going continuous improvement. Acts in consultative role and mentors others and is sought after as such. Good organizational and time management skills. Assists in direction of plant wide or department objectives. Applies knowledge of information / external business challenges to provide input into recommendations for improvement to processes and products. Functions as a subject matter expert on cGMPs and regulatory requirements, as well as plant and divisional processes. Ability to interpret company Quality Policies and Guidelines for daily application. Understands and applies regulatory / compliance requirements, including GMP, NDA, and related regulations, and has the ability to interpret those regulations for implementation in the workplace. Possesses an advanced knowledge of theories, practices, and procedures in the Quality Control Laboratory discipline, including the knowledge and understanding of pharmaceutical operations systems. Possesses advanced technical writing capabilities and is able to compile complex investigations, procedures, justifications, qualifications/validation protocols, agency responses, etc. Possesses an advanced knowledge and ability to operate information systems required to complete job responsibilities with the ability to generate data and reports from these systems in standard and non-standard requests. Solves complex problems and takes a new perspective on existing solutions. Ability to independently respond to advanced requests for data and trending of data from multiple systems and sources and proactively utilizes trending of data to improve the operation or drive change. Explains difficult issues and works to build alignment around a complex situation. Develops presentations which includes those needed to influence the actions and decisions of others and presents to own work team or large groups with limited or no assistance of others. Makes decisions within guidelines and policies that impact a range of standard and non-standard customer or project activities. Ability to apply statistical methods used in defect resolution and data analysis. Accountable for technical contribution to work or project team and may lead or manage a medium scale project with minimal resource requirements, risk, and/or complexity. Has the ability to effectively manage multiple and changing priorities/projects and ensure timely completion. Requires little to no supervision. Required Education and Experience: BS/MS/P.H.D. in science, preferably in Chemistry or Biology, with 4 or more years of pharmaceutical laboratory experience. Required Skills: Adaptability, Adaptability, Analytical Instrumentation, Analytical Method Development, Budget Management, Decision Making, Detail-Oriented,