Incoming QA Specialist

Alcami Corporation•Clinton, TN

5d•Onsite

About The Position

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? As an Incoming Quality Specialist, you are a key member of the Quality Assurance (QA) team, responsible for ensuring all incoming materials—including packaging components, bulk products, and materials—meet required quality and GMP standards before release for use in manufacturing and packaging operations. This is a quality support role with both administrative and inspection-focused responsibilities, emphasizing documentation control, incoming product verification, and customer communication. You will work cross-functionally with Planning, Warehouse, Production, Customer Service, and external customers to ensure materials and documentation are reviewed, approved, released, and archived correctly. Your work helps maintain a clear, traceable, and compliant incoming quality process that supports patient safety, regulatory expectations, and operational efficiency.

Requirements

At least one year of experience in a pharmaceutical cGMP regulatory experience is required for consideration.
Experience working with documentation processes or controlled document systems (paper-based experience is a plus).
High school diploma or equivalent degree is required.
Familiarity with planning, scheduling, and monitoring work to meet quality and timeline requirements.
Strong attention to detail and ability to process information accurately and consistently.
Comfortable working in a compliance-driven, structured environment.
Clear written and verbal communication skills.
Full professional proficiency in English.

Nice To Haves

paper-based experience is a plus

Responsibilities

Perform incoming product checks prior to release for use.
Inspect packaging, bulk, and component materials against approved specifications.
Verify materials and documentation meet quality and GMP requirements.
Support release decisions by ensuring inspection and review activities are completed accurately.
Perform incoming product record review, including documentation inspection, approval, and release.
Prepare batch documentation for customer submission and release.
Support controlled documentation processes, including corrections and follow-up activities.
Ensure all IQA-related documentation is properly reviewed, approved, and archived.
Manage archiving of incoming quality documentation to ensure completeness, traceability, and compliance.
Maintain secure and organized records in accordance with internal procedures and customer requirements.
Act as a reliable point of contact for incoming product quality topics.
Collaborate with Planning, Warehouse, Production, Customer Service, and QA colleagues.
Communicate clearly with internal teams and customers regarding documentation status and quality findings.
Participate in team meetings and contribute positively to team collaboration and engagement.