Overall responsibility for the Quality Control function daily.
Responsibilities:
Direct and supervise personnel and activities within the Quality Control Laboratory
Develop strategic plans for the Department and personnel.
Execute assignments as directed by the Head of Quality Control with no supervision.
Independently manage all laboratory activities for assigned functions and projects. This includes developing timelines, daily (and longer-term) work plans, assignments, and milestones for their direct reports.
Manage, motivate, develop, and coach members of the QC Laboratory to achieve identified objectives, maximize their potential and continuously improve their individual effectiveness in meeting business needs.
In support of other Departments (e.g., QA, RA), execute investigations, deficiency-let1er responses, and CAPA-related activities.
Interface with Analytical R&D, Quality Assurance, Business Development, and Manufacturing Departments for coordination of project activities.
Support formulation development and transfer activities for assigned projects.
Investigate method performance, reliability, and improvement issues, and evaluates proposed changes to compendia! or in-house methods.
Prepare and review technical documents, including validation protocols and reports, reference standard qualification reports, analytical test procedures, Certificates of Analysis; technical reports, change controls and writes investigations and deficiency reports.
Provide training, technical expertise and support to the laboratory staff.
Standardize processes throughout the laboratory. Enforces compliance to cGMP's and SOP's.
Ensure that the analytical procedures developed, reviewed, or established in the laboratory conform to current and appropriate scientific and regulatory standards are suitable for use for their intended purpose.
Develop and implement procedures, systems, and training activities to develop an appropriate level of scientific expertise within the laboratory, to ensure the successful execution of project.
Work to current pharmaceutical-industry technical standards and to maintain compliance with cGMP's.
Audit and review laboratory data generated by their groups.
Recommend the need for new equipment to serve expanding operational and regulatory requirements.
Ensure that specific objectives and goals of the department are met.
Oversee and ensure that all laboratory equipment qualifications, calibrations, and preventative maintenance programs are maintained.
Collaborate with colleagues in Research & Development, Regulatory Affairs, Quality Assurance, and external partners and vendors or contractors to achieve Project goals Supports formulation development and transfer activities for assigned projects and for the filing of new products.
Perform other duties as assigned.
Qualifications:
Bachelor's degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
I0+ years of experience in analytical, organic, or pharmaceutical chemistry within the discipline of analytical chemistry and quality control in the pharmaceutical industry
Current understanding of state-of-the-art analytical instrumentation and equipment.
Must be familiar with the operation and maintenance of the various pieces of analytical equipment and instruments used in the laboratory.
Strong problem-solving ability. Leads investigations and recommends corrective actions.
Ability to mentor and provide best practices to new technicians.
Experience in successfully managing complex technical issues using structured analysis and methodology and articulating clear and concise direction to other operations staff.
Strong experience with project and people management.
Able to administer personnel performance evaluations.
Demonstrate the ability to write and understand technical information and produce detailed reports.
Demonstrates good leadership skills and the ability to establish and maintain good working relationships with other departments, including vendors, colleagues, and subordinates.
Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
Must be able to comprehend and follow all applicable SOPs.
Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
Demonstrate solid understanding on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
Good understanding of cGMPs, industry, and regulatory standards and guidelines.
Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
Demonstrate the ability to portray the appropriate level of integrity and professionalism.
Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
Results-oriented and efficient.
Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
Demonstrate the ability to work well in a cross-functional team environment.
Must communicate fluently in English and have legible handwriting.
Physical Demands:
Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
Ability to lift up to 40 pounds on occasion.
Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).