Senior QC Data Reviewer

ARL Bio Pharma • Oklahoma City, OK

1d • Onsite

About The Position

The Senior QC Data Reviewer position offers the opportunity to play a key role in our laboratory. As a Subject Matter Expert with limited oversight, performs quality reviews and approval of test results and data compliance for a comprehensive range of complex Chemical testing and analysis on pharmaceutical substances. This position will utilize technical expertise to ensure all procedures comply with established protocols and regulations. This position will involve using multiple computers and software to execute daily tasks, including Microsoft Office products, Laboratory Information Management Systems (LIMS), and various other web-based systems. This incumbent will routinely provide technical training sessions, function as a technical resource, and help develop mentors for the Research and Development Department staff. Additionally, collaborating across departments to address complex technical and operational challenges fosters a collaborative work environment. As a technical expert, this position will advise supervisors and contribute to the overall success of the department and business by understanding, interpreting, and developing innovative solutions and best-practice recommendations. May at times lead to less experienced personnel in strategic projects.

Requirements

• Bachelor's degree in Chemistry or related Science Field- or equivalent Diploma.
• 4 years of experience in analytical testing and/or a Research Laboratory.
• Must understand laboratory and scientific equipment and terminology.
• Must be able to analyze and interpret data from various tests including HPLC, LCMS, IC, and/or CCIT, and determine why the data is not consistent with expectations.
• Requires commonly used concepts, practices, procedures, and instrumentation used in a chemistry laboratory.
• Must demonstrate a professional manner reflecting the company image when interacting in person, by email, and by telephone with external and internal agencies.
• Needs to be accurately reported and positioned when interacting and maintaining samples from multiple clients arriving simultaneously.
• Deals with many time-sensitive tasks that must be effectively managed simultaneously.
• Will work at times independently and within a team environment.
• Uses MS Office applications and Laboratory Information Management System (LIMS) daily and must be able to navigate digital and web-based applications.
• Work at times will be repetitive, yet each time strong diligence and accuracy are required.
• Must demonstrate recognition of the value of diverse backgrounds, experiences, and abilities.
• Must be fluent in written and spoken English to receive and communicate information for standard and complex operations and emergencies clearly and accurately.
• Requires visual acuity to read and write words and numbers and to see in the normal visual range including ability to distinguish colors and shapes with or without correction.
• Requires hearing in the normal audio range and communicating accurately with or without correction.

Nice To Haves

• Experience in Laboratory Information Management Systems (LIMS)
• Experience in the Pharmaceutical Industry

Responsibilities

• Strict Adherence to Standard Laboratory, Quality Management Systems (QMS), and current Good Manufacturing Practices (cGMP).
• Serves as a pharmaceutical Chemist Data Review subject matter expert for internal and external agencies.
• Manage multiple Research Projects and coordinate project-related work between company departments.
• Reviews and audits project-related data, documentation, plans, protocols, and other deliverables.
• Communication with clients regarding project and sample test status and high-level details.
• Use of highly technical equipment such as High-Performance Liquid Chromatography (HPLC) and Ion Exchange Chromatography (IC).
• Perform Out of Specifications (OOS) Investigations on various tests and determine and advise appropriate solutions per QMS standards.
• Mentor and assist in the coaching and development of laboratory personnel.
• Research evaluates, advises, and executes the implementation of innovative technologies, techniques, and equipment, and processes to achieve department goals and business objectives.
• Adhere to, use, and maintain Personal Protective Equipment (PPE) and Laboratory Safety Equipment and identify hazards that may arise.
• Complete all safety training, including but not limited to OSHA, Departmental SOPs, and Company Compliance.
• Adherence to all ARL Bio Pharma safety standards, policies, procedures, and protocols.
• Maintain adequate attendance as per department and company expectations.
• Performs all other duties as assigned.

Benefits

• Equal employment opportunities to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, gender identity, national origin, disability, veteran status, genetics, or any other characteristic protected by state, federal, or local law.
• Prohibition of workplace harassment based on race, color, creed, religion, gender, age, sexual orientation, gender identity, national origin, disability, veteran status, genetics, or any other characteristic protected by state, federal, or local law.
• Affirmative action to ensure that applicants and employees are treated without regard to any protected characteristic.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior