Quality Assurance Pharmacist

Be Part of the Team That’s Transforming Healthcare

At FarmaKeio Outsourcing, we’re reshaping the idea of healthcare. We believe medicine should go beyond masking symptoms to uncover and treat the root cause. Every formula we create is designed to restore balance, vitality, and the freedom to live well.

This role requires a profound commitment to detail. You will be meticulously reviewing production activities and documentation as part of the Quality Unit. Ensuring medications designed to restore individual balance and vitality are produced according to the highest quality standards. This precision is the foundation of the patient’s comeback story.

Job Summary

This role performs independent quality oversight and batch disposition activities, and leads or supports core quality systems (deviations/nonconformances, OOS/OOT, change control, CAPA, complaints/recalls, validation/qualification, supplier/material quality, and inspection readiness) to maintain compliance with FD&C Act 503B requirements, applicable USP standards, and cGMP (21 CFR Parts 210/211).

Key Responsibilities

Environmental Monitoring and Testing

· Oversee environmental monitoring, air and surface bioburden, temperatures, and particle counts.

· Collect and document environmental monitoring samples and results.

· Submit samples for testing.

Documentation and Record Keeping

· Review and maintain batch records, and product test results.

· Review quality records, including equipment calibration, maintenance logs, and cleanroom records.

· Support, as needed, other quality documentation requirements.

Validation and Qualification

· Support validation and qualification efforts for equipment, processes, and systems.

· Perform final review of test data and reports; approve or reject product batches as per established standards.

CAPA (Corrective and Preventive Action) Processes

· Assist with root cause analysis and recommend corrective and preventive actions (CAPA) for quality-related issues, including deviations, complaints, and audit findings.

· Use CAPA processes to drive quality improvements and respond to process or service issues.

Compliance and Audits

· Ensure compliance with USP <797>, USP <800>, FDA regulations, and cGMP standards for all quality processes.

· Assist with regulatory audits, inspections, and compliance reporting.

Cross-Department Collaboration

· Collaborate with other departments to identify and implement process improvements in compounding, validation, and laboratory operations.

Safety and Cleanliness

· Implement and enforce safety protocols in laboratory and production areas to maintain compliance.

· Oversee control of product labeling and ensure label accountability.

Qualifications

· Valid Pharmacist License

· Must meet legal and regulatory requirements for handling-controlled substances, including passing a background check and drug screening as required by applicable laws.

· Strong analytical, problem-solving, and critical thinking abilities.

· Excellent attention to detail and organizational skills.

· Ability to work independently and collaboratively as part of a team.

· Effective communication skills for engaging with cross-functional teams, regulatory bodies, and management.

· Proven ability to analyze complex data and troubleshoot effectively.

· Skilled in maintaining accurate and precise documentation to ensure data integrity.

· Proficient in operating and maintaining laboratory instruments and software.

· Commitment to staying current with emerging technologies and industry advancements

Work Environment

· Climate controlled environment. Appropriate personal protective equipment (PPE) must be worn while performing certain tasks.
· Limited exposure to hazardous substances; safety protocols minimize risk.

Physical Requirements

· Close visual acuity needed for computer work and visual inspection activities.

· Frequent use of hands for keyboarding and handling small components.

· Frequent standing, walking, and sitting; prolonged standing may be required.

· Occasional lifting of up to 50 pounds.

· Regular verbal and auditory communication required. Fluent ability to speak and read English.

· Reasonable accommodation is available for individuals with disabilities.

Educational & Experience Requirements

· U.S. College Degree in Pharmacy (example: PharmD (Doctorate of Pharmacy))

· Current active pharmacist licensure in the state of Texas.

· Experience in a 503B outsourcing facility, or manufacturing setting preferred.

· Familiarity with FDA regulations, cGMP, and quality assurance practices.

Training and Culture of Quality

· Support training and qualification programs as needed.

· Promote a culture of quality and patient safety through proactive communication and escalation of quality risks.

Safety and Compliance

· Employees must adhere to all OSHA safety standards to ensure a safe working environment, including proper use of personal protective equipment (PPE) and adherence to infection control procedures.

· Safeguard patient confidentiality in compliance with HIPAA guidelines, ensuring that all patient data is handled securely and appropriately.

· Maintain a commitment to continuing education to stay updated on best practices and innovations in the field.

Your career in pharmaceutical innovation starts here!

The Fine Print:

FARMAKEIO Equal Employment Opportunity (EEO) Statement

FARMAKEIO is an equal opportunity employer committed to fostering an inclusive and diverse workplace. We comply with all applicable federal, state, and local fair employment laws, ensuring equal employment opportunities for all employees and applicants.​Employment decisions at Evexias are based on qualifications, merit, and business needs. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, age, national origin, disability, genetic information, marital or familial status, military or veteran status, citizenship status, creed, domestic violence victim status, caregiver status, or any other characteristic protected under applicable laws.

This policy applies to all aspects of employment, including recruitment, hiring, training, compensation, benefits, promotions, transfers, terminations, and other terms and conditions of employment.

FARMAKEIO is dedicated to maintaining a workplace free from discrimination, harassment, and retaliation, ensuring a respectful and inclusive environment where all employees can thrive.

If you require a reasonable accommodation during the application process or in your role due to a disability or any other protected status, please contact hr@farmakeio.com for assistance.

Texting Privacy Policy and Information:

Message type: Informational; you will receive text messages regarding your application and potentially regarding interview scheduling. No mobile information will be shared with third parties/affiliates for marketing/promotional purposes. Message frequency will vary depending on the application process. Msg & data rates may apply. OPT out at any time by texting "Stop".