Quality Specialist II, Chemist

Knoa Pharma LLC•Wilson, NC

92d•Onsite

About The Position

Knoa Pharma is a public health-driven pharmaceutical company dedicated to addressing the opioid crisis. Our focus is on expanding access to lifesaving overdose reversal medicines and affordable treatments for opioid use disorder. Owned by a not-for-profit foundation, everything we do is centered on improving public health, saving lives, supporting recovery, and bringing forward medicines that make a meaningful difference. Knoa Pharma has a robust generics and branded portfolio of medicines in development to address unmet medical needs, and it supports public health initiatives to address the opioid crisis. Its public health-minded purpose enables the company to expand access to lifesaving opioid overdose reversal medicines and affordable treatments for opioid use disorder – at no profit.

Requirements

BA or BS degree in Chemistry or closely related science
2 years minimum relevant experience
Graduate degree (MS Preferred) with one-year minimum experience
Must demonstrate comprehension of at least two or more analytical technology (HPLC, GC, Dissolution, Automation, or Spectroscopy – UV/Vis, NIR, IR, or AA/AE)
Familiarity with cGMPs and FDA requirements
Fundamentally understand and use applicable quality systems.
Maintain all accurate regulatory documentation.
Collect data to ensure compliance with applicable GMP, GLP, GCP, GAMP (“GxP”) regulations and internal Standard Operating Procedures (“SOPs”)
Maintain current knowledge base within relevant technical discipline of FDA regulations and awareness of the necessity and impact of compliance on the business.
Maintain current knowledge base in relevant technical discipline.
Effective interpersonal, verbal and listening skills.
Knowledge of and adherence to appropriate laws and regulations are critical.

Responsibilities

Perform all assigned testing in a timely and organized manner in accordance with cGMP, GLP, DEA and company policies and procedures.
Accurately document all necessary and relevant information in a clear concise manner as per cGMPs.
Operate and maintain all analytical instrumentation and equipment as per established procedures.
Write, revise, develop and evaluate operational and maintenance procedures.
Communicate openly within the group to provide and gather information, to optimize the use of resources and to optimize efficiency.
Provide training and assistance to other group members.
Actively participate in investigations, problem solving and troubleshooting.
Ensure that equipment and working areas are maintained with good safety and housekeeping practices.
Re-stock chemicals and consumables used in analysis.
Prepare and present data summaries (written and oral) as necessary.
Responsible for compliance with Controlled Substance documentation and accountability procedures and policies while maintaining high alert to diversion and theft possibilities.
Exercises good judgment in interpreting, understanding context, and reporting data.
Proactively identifies potential problems and recommend solutions.
Prepares, writes, and distributes reports as appropriate.
Participates in preparation and revision of job related controlled documents.
Performs analytical testing of samples under limited direction.
Skilled with laboratory equipment, including routine maintenance and calibration.
Proficient with use and understanding of laboratory chromatography software.
Performs other related assignments and duties as required and assigned.