What are the responsibilities and job description for the Quality Specialist position at Pharma Source Direct?
Position Overview:
Join a dynamic, rapidly growing Active Pharmaceutical Ingredient (API) wholesale company. Pharma Source Direct, Inc. is seeking a detail-oriented and proactive Quality Specialist to join our team. The ideal candidate will support all quality assurance activities, ensuring compliance with GMP regulations, company SOPs, and industry standards. This role reports to the Director of Quality, and involves oversight of document control, supplier qualification/monitoring, quality event investigations, and continuous improvement initiatives.
Key Responsibilities:
- Conduct routine reviews of batch records, certificates of analysis, and other critical documentation.
- Administer document control processes. Review and maintain controlled documents such as SOPs, forms, training records, etc.
- Assist in managing nonconformances, deviations, and customer complaints, ensuring timely investigations and effective corrective & preventive actions.
- Support supplier qualification processes, including conducting paper audits and maintaining supplier files.
- Coordinate with external service providers for various API testing requirements.
- Conduct internal audits according to the company schedule.
- Participate in customer/regulatory authority inspections.
- Prepare/submit reports in accordance with Federal/State requirements.
- Lead regularly recurring QA training meetings.
- Collect KPI data for departmental metric reporting.
- Collaborate with cross-functional teams to promote a strong quality culture and continuous improvement.
- Other duties, as assigned.
Qualifications:
- Bachelor’s degree in Life Sciences, Chemistry, or a related field.
- 2 years of experience in quality assurance and/or quality compliance within the pharmaceutical or API industry.
- Familiarity with GMP regulations, FDA guidelines, and pharmaceutical quality systems.
- Strong attention to detail, organizational skills, and the ability to manage multiple priorities.
- Excellent written and verbal communication skills.
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
- Experience with technical writing, investigations, audits, and documentation review is a plus.
- Must be willing to undergo a pre-employment background check and drug screening.
This position is on site only, Monday through Friday from 8:00am-5:00pm. Expected salary starts at $60,000/yr. Pharma Source offers its associates competitive compensation packages including: bonus eligibility, paid medical benefits, optional vision and dental benefits, matched 401k, and a generous paid/personal time off program. Pharma Source Direct, Inc. offers exceptional opportunities for both personal and professional development, fostering a dynamic and open environment that nurtures and encourages you to enhance your skills and talents.