Senior QC Data Reviewer

ARL Bio Pharma; Oklahoma City (OK); On-site; USD 75,000 - 95,000; Full time

Job summary

ARL Bio Pharma, Inc. seeks a Senior QC Data Reviewer to perform quality reviews and approve test results, ensuring data compliance across a comprehensive range of laboratory testing and analysis for pharmaceutical substances.

As a subject matter expert with limited oversight, you will train staff, collaborate across departments, and advise supervisors on innovative solutions and best practices, occasionally leading strategic projects.

Qualifications

• Bachelor's degree in Chemistry or related science field.
• 4 years of experience in analytical testing and/or a Research Laboratory.
• Experience with LIMS and pharmaceutical industry is a plus.

Responsibilities

• Strict Adherence to cGMP and QMS.
• Reviews and audits project data, documentation, plans, and other deliverables.
• Mentor and assist in coaching laboratory personnel and cross-department collaboration.
• Interpret data from HPLC, LCMS, IC and provide appropriate conclusions per QMS.
• Communicate with clients regarding project and sample test status.

Skills

Technical expertise

Leadership

Analytical skills

Communication

Organization

Time management

Collaboration

Digital literacy

Attention to detail

Diversity awareness

Education

Bachelor's degree in Chemistry or related Science Field

Tools

LIMS

HPLC

LCMS

IC

Job description

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.

Work Restrictions

Because of the vital nature of this work, we do not allow medical marijuana cards, and we do random drug testing on all our employees. The Company is subject to certain federal regulations and directives regarding a drug-free workplace. Because of the Company’s federal obligations and directives, as an employee of an analytical laboratory such as ARL Bio Pharma Inc., you will be subject to drug and alcohol testing, including random testing. Marijuana is one of the substances included in the drug panel screening. Possession of a medical marijuana license will not excuse you from the testing process, or the consequences of testing positive for marijuana.

• Essential Functions...
• 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.
• The duties listed are not comprehensive but are a representation of the function this position will perform. Duties that are similar, related, or logical are also included. The omission of specific statements does not exclude them.
• Key Skills, Abilities & Success Factors...
• Technical Expertise: This position must understand laboratory and scientific equipment and terminology.
• Leadership: This position at times mentor department employees on department and industry terminology
• High Analytical/Problem-Solving Skills: This position will need to 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.
• High Technical Capacity: This position requires commonly used concepts, practices, procedures, and instrumentation used in a chemistry laboratory.
• Professional Verbal and Written Communication: This position interacts in person, by email, and by telephone with external and internal agencies and must demonstrate a professional manner reflecting the company image.
• Organization Skills: This position interacts and maintains samples from multiple clients arriving simultaneously and needs to be accurately reported and positioned.
• Time Management: This position deals with many time-sensitive tasks that must be effectively managed simultaneously.
• Collaboration Proficiency: This position will work at times independently and within a team environment.
• Digital Literacy: This position uses MS Office applications and Laboratory Information Management System (LIMS) daily and must be able to navigate digital and web-based applications.
• Detail Proficiency: This position's work at times will be repetitive, yet each time strong diligence and accuracy are required.
• Intercultural sensitivity: This position will work with diverse populations of characteristics and must demonstrate recognition of the value of diverse backgrounds, experiences, and abilities.

Expected Hours of Work

Days and Hours of Work vary by assigned group and tasks depending on business needs. The schedule will be discussed with the supervisor to meet the company's and department's needs. Some Flexibility is required for occasional extensions outside the normal schedule. and weekends may be necessary to meet business needs.

Minimum Qualifications

Education

Bachelor's degree in Chemistry or related Science Field- or equivalent Diploma.

Work Experience

4 years of experience in analytical testing and/or a Research Laboratory.

Preferred Qualifications

Education

Bachelor's degree in Chemistry or related Science Field- or equivalent Diploma

Work experience

4 years of experience in analytical testing and/or a Research Laboratory.

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

Work Environment

• This job operates in a professional Laboratory environment using typical protection equipment (Eye protection, Gloves, Lab Coats, etc.)
• This role routinely involves standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.
• Essential duties of a laboratory environment with periodic exposure to toxic and/or hazardous chemicals, solvents, and other environmental substances
• Exposure to strong odors and varying temperatures.
• The noise level is moderate.
• Primarily dominated English-speaking workplace.
• Attendance at the office is required.
• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential functions.

Physical Requirements

• Routinely stand and walk in the performance of duties, including walking between buildings daily, and some filing is required.
• This position would require the ability to lift 50 Lbs. (if an object weighs more than 50 Lbs. ARL requires this to be a two-person job or the use of carts.
• Ability to sit and stand in front of a computer and/or laboratory equipment for extended periods, with intermittent twisting/bending to reach instruments or supplies surrounding equipment.
• Ability to use hand strength and finger dexterity to perform grasping and fine manipulation of precise equipment.
• Operation of standard office equipment.
• 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.

AAP/EEO Statement

ARL Bio Pharma, Inc. provides 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. ARL Bio Pharma, Inc. expressly prohibits any form 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. Improper interference with ARL Bio Pharma, Inc. employees' ability to perform their job duties may result in discipline up to and including discharge. Further, the company takes affirmative action to ensure that applicants and employees are treated without regard to any of these characteristics.