Sr. Materials Control Technician (GMP)
Alcami Corporation
Sr. Materials Control Technician (GMP)
- Category
- Procurement
- Position Type
- Full-Time
- Working Hours
- 1st Shift: Monday - Friday, 8:00am - 5:00pm
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
The Senior Materials Control Technician is accountable for driving results in a fast-paced environment by following applicable SOPs and cGMPs to perform tasks related to the receipt, storage, inventory and distribution of raw materials, intermediate or finished drugs or drug products and components. The Senior Materials Control Technician also identifies and handles hazardous materials. The Senior Materials Control Technician uses the electronic inventory system to track, document and control all inventory. At the senior level, the Technician demonstrates proficiency in all department procedures and is certified to train other new or less experienced technicians. The Senior Materials Control Technician provides work instruction and oversees daily work assignments in the absence of the supervisor as needed.
On-Site Expectations
- 100% on-site position.
- 1st Shift: Monday - Friday, 8:00am - 5:00pm.
Responsibilities
- Performs sampling and distribution of incoming raw materials, components, in-process batch samples; bulk product, finished product and critical utilities.
- Prepares laboratory packages and project data entry for laboratory testing.
- Develops sampling plans concerning quantity of material required for retains and submission to the laboratory based on the methodology needs outlined in specification.
- Assists with problem solving for transaction discrepancies and tracks the status of projects.
- Communicates and collaborates routinely with other departments.
- Uses multiple computer software programs to log in, manage, and maintain material status and testing requirements.
- Performs peer review.
- Works efficiently in a team setting, with ability to multi-task in a fast-paced environment.
- Adds or removes material from the electronic inventory system.
- Identifies hazardous materials and controlled substance.
- Processes and maintains inventory for retained samples for raw materials and finished product.
- Ships finished product and clinical and commercial batches.
- Follows applicable SOPs and cGMPs to perform assigned duties and tasks.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
- Tracks, documents, and controls appropriate inventory using the electronic inventory system.
- Reconciles raw materials, packaging components, and labeling usage at the time of depletion or disposition.
- Performs daily and weekly cleaning of the warehouse.
- Adds or removes material from the electronic inventory system.
- Disposes of hazardous, toxic, or non-toxic drug and drug product waste.
- Processes and maintains inventory for retained samples for raw materials and finished product.
- Ships finished product for clinical and commercial batches.
- Monitors, confirms, counts, and generates reports to appropriately stock levels for project requirements.
- Assists with periodic cycle counts and end-of-year physical inventory per standards.
- Packages and prepares dangerous good shipments per 49CFR.
- Produces client reports from the electronic inventory system for expired and retest material.
- Produces reports from the electronic inventory system for retain samples and finished product eligible for destruction.
- Identifies and handles hazardous materials and controlled substance.
- Demonstrates proficiency in all department procedures and trains and coaches other technicians.
- Provides work instruction and oversee daily work assignments in the absence of the supervisor as needed.
- Other duties as assigned.
Qualifications
- High school diploma or equivalent required with 6+ years of related experience.
- Associate’s degree preferred.
- Prior pharmaceutical or CDMO and hazardous goods experience preferred.
- Prior hazardous materials management experience preferred.
- Clean driving record required.
Knowledge, Skills, and Abilities
- Knowledge of cGMP and cGMP warehouse practices and procedures required.
- Knowledge of hazardous materials and controlled substances preferred.
- Knowledge of electronic document systems required. Experience using AX preferred.
- Excellent communication, documentation, detail orientation, and organizational skills required.
- Strong computing skills required.
- Ability to operate forklift.
- Ability to train, coach and develop others required.
Travel Expectations
- Up to 5% domestic travel.
Physical Demands and Work Environment
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 use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to stand. The employee is occasionally required to walk; sit and stoop, kneel, crouch, or crawl. The employee must 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, color vision, peripheral vision, depth perception, and ability to adjust focus.
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and risk of electrical shock, burn hazards and microbial contamination. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.
Options
About Us
Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. At Alcami, we are a team of dynamic, agile individuals committed to developing life-saving drugs around the world. A mindset of collaboration, innovation, responsiveness, accountability, and customer focus inspires us to be the most efficient, safe, and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, professional growth, and the opportunity to be part of our skilled team with over 40 years of experience as champions that are dedicated, trustworthy, and relentless to advancing products through every stage of the development cycle. Alcami offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision and prescription coverage, life, LTD, STD, 401(k) with match and immediate vesting, and tuition reimbursement / student loan forgiveness.
Diversity and Inclusion
Alcami is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
Software Powered by iCIMS
www.icims.com