Quality Control Inspector ​/ Quality Assurance Associate

Marlex Pharmaceutical, Inc. a fast growing pharmaceutical company, is seeking a detail oriented, dependable individual whose primary responsibilities would be inspecting incoming components and product shipments from our contract manufacturers/ repackagers, to ensure that the product meets quality standards.

The QC inspector/ Quality Assurance Associate uses a variety of techniques and inspection methods to determine if our components/products meet quality standards. Methods include visual inspections, measurements and functional testing of the product. An inspector must ensure that the product meets specifications in terms of its appearance and its function.

• Inspect all incoming component shipments to ensure that all applicable specifications are met
• Inspect product shipments coming from contract manufacturers/repackagers to ensure that all necessary components meet quality standards
• Help trouble-shoot packaging concerns and communicate with contract manufacturers/ repackagers and vendors
• Verifies and inspects incoming materials and works accordingly with Quality Assurance to handle any possible discrepancies.
• Participates in other quality audits when required
• Complete and maintain documentation of all items inspected and findings/conclusion of findings
• Create/review documents, ie. SOPs, batch records as they pertain to the manufacture of each product line
• Performs batch record review and approval, product release, and disposition
• Ensure that all activities are performed according to documented SOPs/batch records
• Assesses whether batch record information is complete, accurate, and compliant
• Identifies quality concerns and escalates to management as appropriate
• With guidance, works as quality representative on cross functional teams to support new product launches
• Participates in the development and maintenance of QA programs, policies, processes, procedures and controls to ensure that products conform to established standards.
• Participates in prioritizing, scheduling and resource allocation in order to maintain efficient workflow
• Demonstrate behaviors and positive attitudes in line with Quality Assurance values
• Assist with manufacturing floor activities (equipment/room approval, facility compliance)
• Performs other duties as may be required or necessary

• B.S./B.A. (or equivalent) chemistry or life sciences degree
• Good interpersonal communication skills/able to work in a team environment
• Solid computer skills related to word processing (Word) and Spreadsheets (Excel)
• Excellent written and verbal and communication skills
• Detail oriented with ability to detect and articulate nonconforming issues
• Knowledge and understanding of cGMP regulations
• 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
• Able to execute multiple tasks

• The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems.
• The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision without neglecting attention to detail
• The ability to enable and drive change while being focused on internal and external customers.
• Capable to manage multiple priorities.

Proficient in Excel, word and Microsoft Outlook.

Marlex Pharmaceuticals, Inc. is an Equal Opportunity Employer

NOTE:

This job description is not intended to be all-inclusive. Employee may perform other related duties to meet the ongoing needs of the organization.