Quality Specialist II, Chemist

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.

Must demonstrate comprehension of at least two or more analytical technology (HPLC, GC, Dissolution, Automation, or Spectroscopy - UV/Vis, NIR, IR, or AA/AE); and should have a familiarity with cGMPs and FDA requirements.

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.

COMMON ACCOUTABILITIES AND SKILLS:

All positions in the Quality Core Tract require the ability to:

• 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.
• Each professional must possess effective interpersonal, verbal and listening skills. Knowledge of and adherence to appropriate laws and regulations are critical.

Physical and Environmental Requirements

• 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.
• Ability to work a 10 hour per day/4-day work week; 40 hours per week with overtime as required.

Supervisory Requirements (if applicable)

• This role does not have direct supervisory or managerial responsibility.

Additional Information

Relocation is not offered for this position.

Knoa Pharma 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 Knoa.

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 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.