Quality Manager

Company: Aerotek
Location: Buffalo
Posted on: April 9, 2021

Job Description:

Description:Manage Incoming Quality Control (IQC) personnel and related inspection programs. Oversee IQC metrics, inspections and release of incoming materials, investigations, and continuous improvement of the department.Oversee incoming quality control of raw materials, consumables, critical reagents, components, and bulk packaging/labeling for pharmaceutical manufacturing sites. Oversee sampling of raw materials for QC laboratory testing and release for production use.Setup and maintain efficient IQC systems and processes for increasing pharmaceutical manufacturing output and additional sites/locations. Provide cGMP guidance and training to IQC personnel. Ensure IQC areas are in state of compliance and are inspection ready for regulatory agencies audits. Ensure a safe work environment for personnel with compliance to OSHA requirements.Recruit, manage, and schedule of personnel to meet manufacturing and QC laboratory needs.Conduct discrepancy and failure investigations and process applicable MRDRs and CAPAs in a timely manner.Manage departmental budget planning including equipment and instrument purchases to support efficient processes. Create, revise, and/or review operational SOPs, technical documents, protocols, and reports.Establish and promote staff engagement, motivation, and personnel development through coaching and mentorship. Complete staff assessments and performance reviews as required ensuring competencies are maintained.Participate in personnel development programs to further enhance skills and knowledge relevant to the position.Provide input into continuous improvement and KPI metrics development and maintenance.Serve as SME and provide guidance for IQC development, area inspections and compliance, and follow up actions and responses as Provide support for customer and manufacturing related needs while maintaining a high level of professionalism. Manage and support production needs that occur on off-shift hours.Perform other related duties and responsibilities as assignedAdditional Skills & Qualifications:B.S. or advanced degree in an applicable life-science with a minimum of 5 years of experience in pharmaceutical incoming quality control or an Associate degree in an applicable life science with a minimum of 10 years of experience in pharmaceutical incoming quality control.Proven capabilities in reviewing and approving technical documents, master specifications, sampling plans, and other incoming quality documents as applicable.Strong leadership with experience in managing, supervising, and developing employees and teams.Excellent verbal and written communication skills.Ability to effectively communicate and collaborate with multiple levels within the organization to achieve measurable results. Strong focus on quality and safety in compliance with OSHA requirements.In depth knowledge and experience with cGMP 21 CFR 210/211/820 Quality Systems.Working knowledge of laboratory information management systems (LIMS) and experience in leading LIMS implementation and optimization for IQC related functions.Advanced knowledge and implementation of data integrity principles.Advanced organizational and time management skills.Experience and involvement with regulatory inspections as well as internal and external audits. Experience in 5S and lean initiatives is preferred.Experience Level:Intermediate Level About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Buffalo , Quality Manager, Executive , Buffalo, New York