Sr. Quality Specialist I, Chemist (On-site)

Join Knoa Pharma

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.

Job Summary

Perform a variety of chemical analyses and GMP review of raw materials, packaging components, ancillary solutions, in-process samples, finished product samples, and stability samples in accordance with cGMP, GLP, DEA, and company policies and procedures. May author and review protocols for method development, method validation, method transfer, and/or process validation. Execute protocol testing, data review, report writing, and report reviewing. May participate in equipment validation IQs, OQs, PQs, and MQs, if necessary. Provide assistance and technical support to other analysts with chemical testing needs and perform troubleshooting of analytical methods and instrumentation. May be responsible for technical supervision of Quality colleagues and serve as back-up to management to ensure smooth and efficient operation of the lab.

Primary 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.
• Exercise good judgment in interpreting, understanding context, and reporting data.
• Proactively identify potential problems and recommend solutions.
• Prepare, write, and distribute reports as appropriate.
• Participate in preparation and revision of job-related controlled documents.
• Perform analytical testing of samples under limited direction.
• Support the creation, revision and development of test methods, operational and maintenance procedures, and other job-related controlled documents.
• Evaluate accuracy, completeness, and adequacy of reports.
• Independently prioritizes workload.
• Require minimal guidance and supervision when conducting routine and non-routine activities in primary discipline.
• Comply with site and regulatory controlled substance documentation and accountability procedures while maintaining high level to diversion possibilities.
• May interact with other departments/teams within the Company and with external regulatory agencies and business partners.
• Perform other related assignments and duties as required and assigned.

Education and Experience

The incumbent must have a BA or BS degree in Chemistry or closely related science with six years minimum laboratory experience in pharmaceutical or related industries; or a graduate degree (MS Preferred) with 4-7 years' experience. Relevant experience may include academic and/or industry experience and is measured based on the quality and quantity of the experience as it relates to the requirements of the position.

Necessary Knowledge, Skills, and Abilities

Must demonstrate sound comprehension of multiple analytical technologies (HPLC, GC, Dissolution, Automation, or Spectroscopy - UV/Vis, Raman, or IR); and must have a comprehensive knowledge of cGMPs and FDA requirements as well as familiarity with USP and EP monographs.

Additional requirements include:

Problem Solving:

• Effectively identify, describe, and communicate problems and impact in a timely manner.
• Routinely participate in problem resolution.
• Identify, track, and resolve issues to closure.
• Proactively identify potential problems and recommend possible solutions.

Data Analysis/Reporting:

• Evaluate accuracy, completeness, and adequacy of reports.
• Author, revise and annotate job-related controlled documents.

Leadership Competencies:

• May train Quality colleagues in processes and procedures.
• May be responsible for technical supervision of Quality colleagues. This may include:
  • Assigning work
  • Day-to-day supervision
  • Input to performance evaluation
  • Participating in hiring process
• Organize and coordinate activities for assigned projects anticipating future needs.

Supervisory Responsibilities (if Applicable)

The Sr. Quality Specialist I (Chemist) reports to the Manager/Senior Manager. Sr. Quality Specialist I may coach/ mentor junior staff including temporary staff and interns.

Physical and Environmental

• Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching. While sitting for an extended period of time on a routine basis, incumbent may use the following equipment: Personal computer, telephone/ other voice communication devices, copier, fax, scanners, or other specialized equipment used in an office setting.
• Lift and maneuver equipment and materials weighing up to 20 pounds.
• Take samples which may require stretching, bending, or twisting to remove product from the equipment and/or drums.
• Use small hand and power tools to perform incidental maintenance.
• Perform cleaning and assembly/disassembly on laboratory equipment which may require pulling, pushing, or twisting to remove equipment shields, parts, and panels. Equipment and parts could weigh up to 20 pounds. Also requires operation of industrial hose (water) and physical exertion (repetitive wiping, rubbing, and scrubbing) to clean equipment and laboratory surfaces.
• Must possess the ability to detect, recognize, and accurately distinguish defects such as discoloration, particulate matter, and other visual anomalies at close range (18 inches) with or without a reasonable accommodation (magnifiers, prescription glasses) that may affect product quality or patient safety.
• Ability to work a 10-hour per day/4-day work week; 40 hours per week with overtime as required.

Additional Information

Relocation is not offered for this position.

The Company does not sponsor or facilitate any U.S. work or training authorization for this position. All applicants must have unrestricted and independent authorization to work or participate in an internship or training program at the Company.

Minimum required education, experience, knowledge, skills, and abilities are included in the posting. The position will be filled at the level commensurate with the successful candidate's education, experience, knowledge, skills, and abilities.

The job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions. Additionally, the company may revise the job description at any time.

We are an Equal Opportunity Employer. Qualified applicants will receive consideration without regard to: actual or perceived race, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), national origin, ancestry, citizenship status, religion, color, age, creed, sexual orientation, marital status, gender identity or gender expression (including transgender status), protected medical condition as defined by applicable state or local law, genetic information, physical or mental disability, veteran status and military service, or any other characteristic protected by local, state, or federal laws and ordinance.

For more information about your rights under Equal Employment Opportunity, visit:

• EEOC Know Your Rights
• USERRA Rights
• Family and Medical Leave Act (FMLA)
• Employee Polygraph Protection Act (EPPA)
• E-Verify (English and Spanish)
• Right to Work (English and Spanish)

We strive to make our Career opportunities website accessible to all users. If you need an accommodation to participate in the application or hiring process, please email the Knoa Pharma LLC Talent Acquisition team at [click to reveal email address]careers@pharma.com. This email is not for general employment inquiries or vendors; rather it is strictly for applicants who require assistance.

The Company does not seek or accept unsolicited resumes or CVs from recruitment agencies. We are not responsible for any fees, commission, or any type of payment related to unsolicited resumes or CVs except as required in a written agreement between the Company and the recruitment agency or party requesting payment of a fee.

Under certain state law, we may be required to provide a reasonable estimate of the salary range for the jobs covered by this description. Actual salary determinations will take into account factors such as work location, prior education or training and experience, job related knowledge, and demonstrated skills aligned with the Company's internal leveling guidelines and benchmarks. Resumes may be considered in the order they are received.