Quality Assurance Associate

GENOHOPE PHARMACEUTICALS USA

New York, NY Job Details Full-time $60,000 - $80,000 a year 1 day ago Benefits Health insurance Dental insurance 401(k) Paid time off Qualifications Biology Teamwork Microsoft Excel Bachelor's degree Continuous improvement Attention to detail Productivity software Standard operating procedures (SOPs) Cross-functional communication Customer complaint resolution Full Job Description Position Overview The Quality Assurance Associate will support the implementation and maintenance of Genohope Pharmaceutical USA's Quality Management System (QMS), with a focus on pharmaceutical ingredient storage, handling, distribution, and documentation. This role will assist with quality documentation, supplier qualification, warehouse quality monitoring, deviation management, and regulatory inspection readiness. The ideal candidate has a strong understanding of pharmaceutical quality principles, excellent documentation skills, and the ability to work collaboratively with Operations, Warehouse, Supply Chain, and international quality teams. This is a hands-on individual contributor position offering opportunities to gain experience in pharmaceutical quality systems and regulated distribution operations. Key Responsibilities 1. Quality Management System (QMS) Support Assist with the implementation, maintenance, and continuous improvement of the company's Quality Management System. Draft, review, update, and maintain Standard Operating Procedures (SOPs), work instructions, and quality records. Support document control activities, including version control, approval tracking, and record retention. Maintain quality logs, training records, and other controlled documentation. Assist with internal quality reviews and continuous improvement initiatives. Support quality processes aligned with applicable regulatory requirements and company procedures. 2. Pharmaceutical API Quality Assurance Support quality activities related to the receipt, storage, handling, and distribution of peptide APIs and other pharmaceutical ingredients. Review Certificates of Analysis (COAs), product specifications, and related quality documentation for completeness and consistency. Verify product identification, lot numbers, quantities, and applicable expiration or retest dates against supporting records. Assist with incoming material documentation and quarantine procedures. Maintain product traceability and quality records throughout the distribution process. Identify and escalate discrepancies or potential quality concerns to the authorized quality representative. Support product status tracking and release documentation in accordance with approved procedures. 3. Warehouse & Distribution Quality Support Monitor compliance with established warehouse SOPs and quality requirements. Assist with reviewing receiving, storage, inventory, and shipping records. Support warehouse temperature monitoring and environmental recordkeeping. Document and escalate temperature excursions, product damage, and storage deviations. Assist with warehouse qualification activities, temperature mapping, and equipment monitoring when applicable. Support inventory reconciliation and verification of product segregation. Collaborate with warehouse personnel to ensure appropriate handling and storage practices. 4. Supplier & Manufacturing Partner Quality Support Assist with supplier qualification and periodic supplier evaluations. Collect, review, and organize supplier quality documentation, including relevant GMP information, audit reports, and quality agreements. Maintain supplier qualification records and approved supplier documentation. Coordinate quality documentation requests with international manufacturing partners. Track supplier-related quality issues and follow up on corrective actions. Support supplier audits and quality assessments as assigned. 5. Deviation, CAPA & Change Control Assist with documenting deviations, nonconformances, and quality incidents. Support investigations and root cause analysis under the guidance of authorized quality personnel. Track Corrective and Preventive Actions (CAPA) and follow up on assigned action items. Maintain deviation, CAPA, and change control records. Assist with quality risk assessments and implementation of approved changes. Identify recurring quality issues and communicate findings to the appropriate teams. 6. Regulatory Compliance & Audit Support Support compliance with applicable FDA, New York State, and other relevant pharmaceutical distribution requirements. Assist with preparing quality documentation for regulatory applications, renewals, and inspections. Maintain organized and inspection-ready quality records. Participate in internal audits, customer audits, and regulatory inspections as assigned. Track audit findings and assist with corrective action follow-up. Support implementation of applicable quality and regulatory requirements under the direction of authorized personnel. 7. Customer Quality & Documentation Support Coordinate customer requests for Certificates of Analysis, product specifications, and other approved quality documentation. Assist with customer quality questionnaires and supplier qualification requests. Document product quality complaints and coordinate follow-up with relevant teams. Support product traceability exercises, recall readiness, and mock recalls. Maintain complaint records and assist with quality trend analysis. Escalate potential product quality issues promptly. 8. Training & Cross-Functional Collaboration Maintain employee quality training records and assist with SOP training coordination. Support the implementation of quality procedures across warehouse and operational teams. Collaborate with Operations, Warehouse, Sales, Customer Service, and international quality teams. Provide guidance on established quality procedures within the scope of assigned responsibilities. Identify opportunities to improve documentation accuracy, workflow efficiency, and quality compliance. Qualifications & Competencies Required Qualifications Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, or a related scientific discipline, or equivalent relevant experience. Strong understanding of pharmaceutical quality principles and documentation practices. Excellent attention to detail and ability to maintain accurate quality records. Strong organizational, analytical, and problem-solving skills. Proficiency in Microsoft Office, particularly Excel and Word. Ability to follow established SOPs and work within a regulated environment. Strong written and verbal communication skills. Ability to work independently while collaborating effectively with cross-functional teams. Commitment to quality, compliance, and continuous improvement. Preferred Qualifications 2+ years of experience in pharmaceutical Quality Assurance, Quality Control, biotechnology, or regulated distribution operations. Experience with pharmaceutical APIs or peptide-based products. Familiarity with pharmaceutical

QMS, GMP

principles, and ICH Q7. Experience reviewing COAs, product specifications, and quality documentation. Familiarity with deviation management, CAPA, change control, and document control. Experience supporting supplier qualification or quality audits. Knowledge of pharmaceutical warehouse operations, temperature monitoring, and distribution quality requirements. Experience with electronic QMS or document management systems. Mandarin Chinese proficiency is preferred to facilitate communication with international teams.

Compensation & Work Arrangement Annual Base Salary:

$60,000-$80,000, depending on qualifications and experience (proposed).

Employment Type:

Full-Time.

Location:

New York City, NY.

Work Arrangement:

On-site.

Experience:

2+ years preferred. Why Join Genohope Pharmaceutical USA? At Genohope Pharmaceutical USA, you will have the opportunity to contribute to the development of our U.S. pharmaceutical quality operations. This position offers hands-on experience in Quality Management Systems, pharmaceutical ingredient distribution, regulatory compliance, and international supplier quality coordination. You will work closely with Operations, Warehouse, and international quality teams while supporting the implementation of quality processes for our expanding business. We value attention to detail, accountability, collaboration, and a commitment to maintaining high standards of quality. If you are a motivated Quality Assurance professional interested in developing your career in the pharmaceutical industry, we encourage you to apply. Equal Employment Opportunity Genohope Pharmaceutical USA is an equal opportunity employer. We are committed to providing equal employment opportunities to all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by applicable law.

Pay:

$60,000.00 - $80,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off

Work Location:

In person