QC Supervisor
This role provides Supervisory oversight of the analyses, inspection, and tests of products, raw materials, in-process materials, release test samples or stability samples, packaging materials, quantitative assays on samples, and/or finished products from manufacturing/incoming, to ensure quality standards and compliance with company standards, customer and governmental regulatory requirements, and tolerance specifications for the chemical or physical property. Oversees performance of a variety of qualitative tests or quantitative tests on samples using techniques that vary from standard analytical equipment to highly modern and automated instrumentation, aides in maintenance and certification of test instruments and apparatus to ensure compliance. May be involved in establishing requirements for transfer of methodology from R&D. Performs required inspections, checks, analysis and documentation of studies. Prepares and monitors quality statistics and reports. Conducts Laboratory Investigations and Deviations analysis as typical duties.
Essential Duties / Functions:
• Responsibilities include, but are not limited to supervisory oversight of raw material, packaging component, in process, finished goods, manufacturing equipment cleaning and/or stability testing. Provides technical and administrative expertise to ensure all testing and documentation is conducted in accordance with regulatory and company requirements.
• Support of manufacturing operations through timely testing and release of raw material/component or in-process and finished goods samples.
• Provide analytical resources to assure completion of process support, method transfers and stability studies within department budget and established timeframes.
• Recruit, develop and train quality control chemists, and data auditors and other lab technical support (Technicians).
• Ensures all appropriate training documentation is in place.
• Manage instrument usage within the assigned group.
• Provides technical review of Quality Control documents such as Change Controls, CAPA, Analytical Test Methods, specifications, method validation and transfer, Standard Operating Procedures and other documentation.
• Works with development groups to ensure compliant and efficient methodology is transferred to the QC laboratory.
• Audit laboratory data and approve / release laboratory samples.
• Author, maintain and manage departmental Standard Operating Procedures as appropriate
• Interact, cooperate and motivate across departments and functions. Lead by example, and set a high level of team cooperation. LI-CA1*
Requirements:
Qualifications Skills and Specific Knowledge Required:
• Analytical skills
• Knowledge of chromatography and HPLC/GC analysis
• Knowledge of compendia procedures where applicable to their group function (i.e., USP, NF, BP etc.).
• Computer proficiency (i.e., Millennium / Empower, TrackWise, Microsoft Office applications, etc.).
• Possess mathematical skills (i.e., fractions, percentages, ratios and algebraic expressions, etc.).
• Instrumentation knowledge and troubleshooting (i.e., HPLC, GC, UV, IR, KF, pH, etc.)
• Good understanding of cGMP Desirable
• Strong analytical and statistical background with focus on data interpretation
• Good organizational and team building skills
• Innovative thinking
Core Competencies:
• Analytical and technical capabilities
• Good understanding of cGMP and FDA regulations
• Problem solving
• Good instrumentation/software knowledge
• Organizational skills
• Time management
• Collaboration with other groups/departments
• Costumer focus
• Leadership
• Analyzing problems, identifying alternative solutions, and implementing recommendations for resolution of problems.
• Communicating clearly and concisely, both orally and in writing.
• Establishing and maintaining cooperative working relationships with those contacted in the course of work.
Education Required:
• B.S. in chemistry or related science degree.
• Proficient in Windows based environment including word processing, Excel spreadsheet and database programs.
• Ability to author deviation reports Desirable
• MS in chemistry or related degree.
• Accelerated leadership behaviors and ability to influence others
• Training in six sigma Experience Required:
• A minimum of 4 years working in the laboratory setting/pharmaceutical industry.
Options Apply for this job online Apply
Share
Refer this job to a friend Refer
Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed
Connect With Us! Not ready to apply? Connect with us for general consideration.
Do YOU have great ideas? Want to work in an environment that will nurture your professional development? Come and join Teva on its journey of growth. Teva has been cultivating excellence for over a century, and is, today, the worldwide leading generic pharmaceutical company and one of the top 10 pharmaceutical companies in the world. As a forward-looking global pharmaceutical company, Teva spearheads the development, production and marketing of a wide range of specialty, generic and over-the-counter medicines.
With 58,000 employees in over 60 countries worldwide, we are proud to say that our employees are the reason for our sustained success. Their skills and dedication make us an industry leader. The diversity of perceptions, qualifications and talent are the key to our ongoing accomplishments. We offer a wide range of jobs and genuine opportunities for personal and professional advancement.
