Incoming QA Specialist

Alcami-5; Michigan; On-site; USD 52,000 - 72,000; Full time

Job summary

Alcami is seeking an Incoming Quality Specialist to join our QA team. This 100% on-site position focuses on ensuring incoming materials, packaging components, and documentation meet GMP standards prior to release for manufacturing and packaging operations.

The role emphasizes documentation control, cross-functional collaboration, and clear communication with internal teams and customers to support patient safety and regulatory expectations.

Qualifications

• At least one year of pharma cGMP regulatory experience required.
• Experience with documentation processes or controlled document systems.
• High school diploma or equivalent required.

Responsibilities

• Incoming Quality & Product Control: perform checks prior to release.
• Inspect packaging, bulk, and components against specifications.
• Verify materials and documentation meet GMP requirements.

Skills

Attention to detail

Quality Assurance

Documentation

English proficiency

Cross-functional collaboration

Education

High school diploma or equivalent

Tools

Document control systems

Job description

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?

Job Summary

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 bothadministrative 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.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 7:00am - 3:30pm.

Responsibilities

Incoming Quality & Product Control

• 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.

Documentation Review & Control

• 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.

Archiving & Record Management

• 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.

Communication & Cross-Functional Collaboration

• 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.

Qualifications

• 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.

Knowledge, Skills, and Abilities

• 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.

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance.

The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, or manufacturing areas for inspections or work discussions. The noise level in these additional work areas may be louder. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.