Compliance Specialist in Dallas, Texas at Mark Cuban Cost Plus Drug Company

JOB TITLE: Compliance Specialist DEPARTMENT: Quality

REPORTS TO: Quality Unit EMPLOYEE STATUS: Exempt

LOCATION: On-site WORK AVAILABLE: Full-Time

JOB SUMMARY:

As a Compliance Specialist, you will perform document reviews, supports audits, track CAPAs, maintains regulatory logs; learn GxP frameworks; support regulatory submissions or internal policy upkeep.

DUTIES & RESPONSIBILITIES:

• Support the review and maintenance of GMP documentation, including SOPs, batch records, and validation protocols, to ensure compliance with internal and regulatory requirements.

• Assist in tracking, trending, and follow-up of deviations, CAPAs (Corrective and Preventive Actions), and change controls to ensure timely closure and regulatory compliance.

• Participate in internal audits and prepare supporting materials for regulatory inspections (e.g., FDA, TXDSHS, Boards of Pharmacy).

• Help maintain compliance databases and quality metrics, generating reports for Quality and Operations leadership.

• Review executed manufacturing records for accuracy, completeness, and adherence to GMP standards.

• Support training programs to ensure personnel are current with compliance and quality requirements.

• Stay current with relevant regulatory guidelines (21 CFR Parts 210/211, FDA, ICH guidelines) and company policies.

• Collaborate cross-functionally with Manufacturing, Quality Assurance and Engineering to support compliance initiatives.

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in Life Sciences, Biomedical Sciences, Pharmaceutical Sciences, Chemistry, Engineering, or a related field.

• 0–2 years of relevant experience in pharmaceutical, biotech, or regulated manufacturing environments (internship or co-op experience acceptable).

• Familiarity with GMP, GLP, or ISO quality systems through coursework, internship, or project work.

• Strong attention to detail, organizational skills, and ability to work in a team environment.

• Proficiency with Microsoft Office (Word, Excel, PowerPoint) and basic data entry/reporting tools.

• Excellent written and verbal communication skills.

• Preferred Internship or co-op experience in a GMP-regulated environment (manufacturing, QA/QC, regulatory).

• Preferred Familiarity with 21 CFR 210/211, ICH Q10, or equivalent international guidelines.

• Experience with electronic quality systems is preferred.

KEY COMPETENCIES

• Regulatory Awareness – Basic understanding of pharmaceutical regulations and willingness to deepen knowledge.

• Analytical Thinking – Ability to analyze deviations and data to identify potential compliance risks.

• Communication – Clear and professional communication across functions and levels.

• Adaptability – Comfortable working in a fast-paced, highly regulated environment.

• Integrity – Commitment to ethical behavior and data integrity principles.