Qc Scientist Iii

Nature and Scope
Scientist III will perform development, optimization and validation of analytical methods used to determine chemical identity, potency and purity of raw materials and pharmaceutical products manufactured at American Regent, Inc. The individual will design validation activities and provide technical expertise and oversight regarding analytical equipment and systems functioning as an officially documented and sanctioned subject matter expert (SME).
Essential Duties and Responsibilities
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Perform optimization of existing analytical methods and develop new methods based on the current regulations and using latest available analytical equipment capabilities.
• Write technical protocols and reports based on appropriate guidance requirements.
• Design and execute Method Validations, USP method verifications and method transfer protocols.
• Assist the QC group by providing technical guidance regarding analytical or laboratory-based systems.
• Participate in selection and qualification of new equipment and software.
• Provide expertise and assistance to QC analysts during introduction of new test procedures and associated equipment.
• Perform periodic reviews of USP content, Regulatory Guidance documents and other Compendia against internal documentation.
• Map and optimize current methods/process/practices to assure regulatory compliance.
• Perform troubleshooting activities, root cause analysis, and corrective action planning for method related investigations.
• Liaise with other functional departments such as Validation, Metrology, Health and Safety, GxP, IT, R&D, etc. in order to provide technical guidance.
• Ensure all work is performed and documented in accordance with existing company policies, procedures, current Good Manufacturing Practices, and health and safety requirements.
• Assist in general operation of the laboratory, including maintenance of inventory, general upkeep and compliance with industry/company standards
• Perform revisions of procedures requiring modifications and assist in preparation of document change controls as needed.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• BS Degree in Chemistry or related science with minimum of five (5) years in pharmaceutical laboratory or MS Degree in Chemistry or related science with three (3) year pharmaceutical experience.
• Strong background and solid proficiency with techniques and instrumentation used in analytical laboratory (e.g. HPLC, GC, UV-VIS, ICP, IC, etc.)
• Experience in Method Development and Method Validation.
• Thorough understanding of cGMP, requirements of FDA and other international regulatory agencies as well as GAMP, PIC/S, and other quality system guidance systems.
• Ability to prioritize and perform multiple tasks simultaneously.
• Ability to work well in a matrix environment, particularly with QA/ QC, R&D, Validation, Metrology, Health and Safety, GxP and IT.
• Innovative and collaborative mindset is required
• Knowledge of pharmaceutical lifecycle management is a plus.
• Excellent organizational, interpersonal and communication skills are required.
• Strong computer-based skills (Microsoft Office Suite).

Physical Environment and Requirements

• Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
• Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.
• Employees must maintain a clean-shaven appearance to wear tight-fitting respirators properly.
• Position requires working in the laboratory as well as sitting at the desk.
• Employee must be able to occasionally lift and/or move up to 25 pounds.

Expected Salary Range :
$100,400- $115,000
The salary range displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.
American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide
range of other benefits.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.