Nature and Scope of Job

The QC Analytical Scientist II will support various Quality Control activities within the AQC department. Key responsibilities are to transfer and execute analytical methods, including raw materials, for use in a CGMP environment in Quality control, both analytical quality control methods (AQC) and Quality Control Microbiology methods (QCM).

Primary Responsibilities

• Drive special projects that require AQC attention/leadership.
• Drive analytical method development and validation of laboratory methodologies and instrumentation. This includes leading analytical/microbiology QC efforts to support the introduction of new product testing, modifying existing laboratory space, plan design new laboratory spaces and working with vendors to purchase new instruments, and the installation and qualification of new instruments.
• Support investigations and manufacturing investigations requiring analytical method support.
• Support the installation, operational qualification (IOQ), maintenance and troubleshooting of instrumentation in the AQC group.
• Serve on project teams, in a leadership role as needed, which will require substantial interaction and communication with other group functions.
• Upgrading of analytical technologies within an established licensed technology platform.
• Support the execution and issue resolution (e.g., discrepancies) and completion approval of test plans/protocols
• Support troubleshooting of analytical methods and instruments and support laboratory investigations as needed to provide scientific justification for initial Out of Specification (iOOS), Out of Trend (OOT), and atypical result investigations
• Review and approve laboratory investigations, deviations, CAPAs, and periodic reviews, and other documentation that requires advanced analytical knowledge.
• Ensure all laboratory equipment is maintained in a validated state and that all analytical methods transferred follow company and regulatory requirements.
• Responsible for protocol and report generation as well as authoring CMC submission and other technical documents as required. This includes supporting raw material qualification for new products
• Manage and perform assay control and critical reagent qualifications, including monitoring and trending of method performance.
• Support the analysis of QC data using statistical tools to identify trends and set limits for results, including data transcription/entry
• Use sound scientific principles and statistical techniques to solve problems and make recommendations.
• Responsible for deliverables to ensure timelines and milestones are met.
• Support scheduling of AQC and QCM testing (release, execution of protocols, etc.).
• Lead small teams as needed to accomplish tasks.
• Representative for Analytical projects with global and local site functions. Ensure Right First Time (RFT) in the method introduction and instrument qualification process
• Other duties as assigned.

Additional Responsibilities

• Performs other related duties and assignments as required

Qualifications

• Excellent technical writing skills and able to write technical documents and reports that meet company and regulatory requirements
• In depth knowledge of analytical methods and operations with strong emphasis in problem-solving.
• Knowledge about analytical method validation and critical reagent qualification.
• Intermediate statistical knowledge and experience with data analysis.
• Knowledge concerning cGMP, especially lab related topics such as method validation and2 unexpected results investigation.
• Basic knowledge about regulatory requirements concerning analytical instrumentation, test methods and licenses.
• Substantial knowledge and understanding in terms of regulatory standards requirements e.g., CGMP, QSR, USP, 21CFR, ICH etc.
• Ability to complete tasks with minimal direction, demonstration of basic project management skills.
• Ability to multi-task in a highly dynamic and diverse environment.
• Attention to detail, good organization, and time management skills to meet deadlines.
• Proficient in Microsoft Office.
• Strategic and business-oriented thinking.

Education & Certifications

• Bachelor's degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent.
• Minimum of 3 years of analytical development or validation experience in GMP Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Compensation

Salary/Hourly Rate Range (W2): USD 50.00 - 60.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM's compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate's qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.

Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.

All employees are eligible for USDM's rewards and recognition program.

For more details about our benefits, visit us here: https://usdm.com/careers