Senior QC Data Reviewer

• 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 positions 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.

• 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.

• 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.

Required Experience:

Senior IC