Quality Incoming Materials Technician I

Essential job duties

Inspect and sample incoming material to verify identity, quantity, and quality of all raw materials and components to be used in the making of a drug product

Perform raw material (chemicals/components) sampling and measurement using aseptic and other techniques in addition to hand measurement instruments

Communicate with internal laboratories and third-party laboratories to adhere to testing schedule and keep our organization informed of testing deadlines

Collaborate with Quality Assurance Operations department to meet timelines for material review

Write and review Material Specifications

Identify, initiate, and write departures (Non-Conforming Material Reports, Deviations, CAPA, CCR, and others)

Interpret chemical and microbiological test results to generate Certificates of Analysis

Follow all standard operating procedures and participate in/write revision for continuous improvement as needed

Ship samples to third party laboratories for testing, track estimated completion dates, and report out results upon receipt

Create labels for raw materials and finished products

Complete necessary documentation and labelling for material receipt, shipment, testing, and release while following Good Documentation Practices (GDP) at all times

Release materials from Quarantine to the Warehouse in ERP system

Maintain sampling supply inventory

Clean and organize all sampling equipment and sampling room to maintain the department in an “Audit Ready” state

File and archive paperwork

Education, experience, certification and licensures Required

· Associate’s degree or equivalent in education & experience

Preferred

· Bachelor’s degree in Chemistry, Microbiology or related field

Knowledge, skills and abilities

Strong understanding of USP, EP, JP and other Compendia

Ability to work autonomously

Understanding of raw material testing requirements

An understanding of hand measurement tools including but not limited to Verniers, calipers, and pin gauges

Must be skilled in the use of computers and proficient in the use of Microsoft Word and Excel

Must have strong organizational skills and ability to prioritize and multitask

Must be able to pass a sterile gowning qualification as a condition of employment

Physical requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

Work environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and risk of electrical shock (always being aware of one’s environment and taking proper precautions is required). The noise level in the work environment is usually moderate.Employee will be responsible for generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.