Manager QC Raw Materials

Overview

The primary role of the Manager QC Raw Materials is to manage the QC Raw Material testing program in support GMP manufacturing. This role will work closely with the other QC personnel, Quality Assurance, Manufacturing, Process Development, Analytical Technologies and Supply Chain to ensure incoming raw materials are sampled and tested in a timely manner to support manufacturing operations. Develop and implement methodologies for the qualification and testing of Raw Materials, and components utilized in finished products and developmental products; troubleshoot analytical instrumentation within the laboratory.  Managing the activities of the QC department and leading the development and implementation of best practices, processes.  

Responsibilities

• Manage the Raw Material Program in compliance with current GMPs, USP, ICH, EP, JP and FDA guidance documents which includes developing raw material strategies, perform risk assessments and routine raw material testing
• Serve as the subject matter expert for raw materials providing technical expertise aligned with cGMPs, compendial requirements and industry expectations
• Provide oversight to internal and external raw material testing which includes review and approval of test data
• Coordinate and manage external contract testing labs which includes shipping samples, tracking progress and managing timelines
• Assists with method transfers and method validations
• Evaluate the current raw material program and implement improvement where needed to ensure compliance with current regulatory requirements
• Working closely with QA to support the Supplier Qualification program
• Evaluate changes to existing raw materials and potential new raw materials to revise or establish release and qualification requirements
• Author, review and approve out of specification and out of trends investigations, deviations, CAPA's and Change Controls
• Manage the Compendial program by assessing changes to the compendia and lead change for revised compendial testing and monographs where applicable and aligned with cGMPs, GDPs and GLPs.
• Serve as an active member of the Material Review Board
• Author and review CMC sections for regulatory submissions
• Embraces a team working environment focused on achieving department goals by demonstrating willingness to accept assignments not specifically listed in the job description as allowed by the limitations of training, experience, and/or education.
• Ensure that his/her team adheres to safety rules and awareness, demonstrating good safety practices at all times. Taking the initiative to report and correct safety hazards. Making sure that raw material team uses Personal Protective Equipment (PPE) associated with assigned tasks.
• Promotes the values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.
• Executes against project plans and goals as assigned by Quality Management.
• Promotes teamwork environment to meet productivity, quality and department metrics.​
• Enforce strict good documentation practices per company's SOP and cGMP regulation.​
• Monitors laboratory resources, identifies/reports resource gaps, and assists in recruiting, screening, procuring, and/or qualifying needed resources.
• Works independently and is able to facilitate non-routine assignments.
• Support QCRM Team on instrument/​method troubleshooting within analytical method parameters.
• Focus resources on writing, revision, reviews, and implementation of technical documentation including protocols, reports; reference standard qualification reports; analytical test procedures; and change controls.​
• Reviews and/or writes technical reports, procedures, and protocols.
• Supports the investigation program ensuring the team participates in Root cause determination and on time closure of investigations.
• Documents, develops and applies strategies to ensure achievement of scientific objectives by monitoring/ evaluating the completion of tasks.
• Establishes policies, procedures, and practices associated with laboratory activities including safety, testing, scheduling and documentation.
• Schedules laboratory testing and associated activities to minimize operational disruptions to departments.
• May perform internal audits of Quality Control.
• May perform external audits of vendors with respect to laboratory GMP’s.

Qualifications

Competencies:

• Strong writing and oral communication skills.
• Computer literacy in Microsoft Word, Excel, and PowerPoint.
• Ability to work under pressure with multiple tasks and deadlines.
• Ability to work independently as well as with key internal and external constituents. 
• Strong organizational skills. 
• Ability to multi-task and integrate project segments.

Education / Experience:

Bachelor's or advanced degree in biology, biochemistry or closely related scientific discipline with at least 10 years of cGMP QC experience in pharmaceutical setting. At least 3 years of direct supervisory or management experience, including leading teams, reviewing technical documents, and handling vendor or supplier quality issues, expertise in compendial testing and monographs is required. Broad knowledge of scientific principles and methods, wet chemistry, chromatographic analysis, analytical methods (i.e., HPLC, GC, UV), and an understanding of separation theories. Knowledge of current industry standards and expectations (cGMP/GxP, ICH, Compendial, EP, JP, FDA guidance) is required. Analytical method transfers and validation experience is desired. Experience in leading projects; highly organized.  PC literate with basic knowledge of Microsoft office application software.

Judgment / Decision Making:

Work Environment: Air-conditioned office environment.  Majority of time is spent sitting at desk, operating computer and talking on telephone.

 Laboratory environment with exposure to chemicals, caustics, fumes, electrical current, and odors.

Physical Demands:

Visual acuity and manual dexterity required to operate laboratory equipment, computer, and proofread documents.