QUALITY CONTROL INSPECTOR / QUALITY ASSURANCE ASSOCIATE

About the role

Marlex Pharmaceutical, Inc., a fast-growing pharmaceutical company, is seeking a detail-oriented, dependable Quality Control Inspector / Quality Assurance Associate. The primary responsibility is inspecting incoming components and product shipments from contract manufacturers and repackagers to ensure they meet quality standards. The role involves using various techniques and inspection methods, including visual inspections, measurements, and functional testing, to verify that products meet appearance and functionality specifications.

Responsibilities

• Inspect all incoming component shipments to ensure compliance with applicable specifications.
• Inspect product shipments from contract manufacturers/repackagers to verify all components meet quality standards.
• Troubleshoot packaging concerns and communicate with contract manufacturers, repackagers, and vendors.
• Verify and inspect incoming materials, collaborating with Quality Assurance to address discrepancies.
• Participate in quality audits as required.
• Complete and maintain documentation of all inspected items and findings.
• Create and review documents such as SOPs and batch records related to product manufacturing.
• Perform batch record review and approval, product release, and disposition.
• Ensure all activities comply with documented SOPs and batch records.
• Assess batch record information for completeness, accuracy, and compliance.
• Identify quality concerns and escalate to management as appropriate.
• Act as a quality representative on cross-functional teams to support new product launches, with guidance.
• Participate in developing and maintaining QA programs, policies, processes, and controls to ensure product conformity to standards.
• Assist in prioritizing, scheduling, and resource allocation to maintain efficient workflow.
• Demonstrate behaviors and attitudes aligned with Quality Assurance values.
• Assist with manufacturing floor activities, including equipment/room approval and facility compliance.
• Perform other duties as required or necessary.

Requirements

• B.S./B.A. (or equivalent) in chemistry or life sciences.
• 3-5 years of quality assurance manufacturing experience in the pharmaceutical industry.
• Excellent knowledge of pertinent SOPs, GMPs, and related compliance regulations and guidances.
• Knowledge and application of good documentation practices.
• Strong interpersonal and teamwork skills.
• Solid computer skills, including proficiency in Microsoft Word and Excel.
• Excellent written and verbal communication skills.
• Detail-oriented with the ability to detect and articulate nonconforming issues.
• Understanding of cGMP regulations.
• Able to execute multiple tasks.

Preferred Qualifications

• Ability to build and maintain relationships across multiple departments to solve problems effectively.
• Strong organizational skills to prioritize and deliver tasks with urgency and minimal supervision while maintaining attention to detail.
• Ability to drive change while focusing on internal and external customers.
• Capable of managing multiple priorities.
• Proficient in Microsoft Outlook.