Plastikon Healthcare is looking for an Incoming Material Specialist supporting day-to-day activities relating to the inspection and sampling of all incoming raw materials, packaging components and labeling. The position will support pharmaceutical and medical device manufacturing operations under the direction of the Quality Assurance Manager. The incumbent is responsible to follow company policies, cGMP’s, and all Standard Operating Procedures as mandated for this position.
- Perform inspection and sampling where applicable on all incoming labeling, raw materials and packaging components following detailed written procedures and specifications.
- Preparation of samples for chemical and microbiological analysis and delivering them to the Quality Control Lab.
- Maintaining detailed records of sampling and inspection activities.
- Inspects incoming materials by confirming specifications, conducting visual inspection, and managing non-conforming product processes, if needed.
- Assigning and verification of expiry date for all GMP raw materials through vendor Certificate of Analysis (CoA) and/or in-house CoA.
- Documents inspection results by completing logs and reports.
- Compliance of Warehouse areas in terms of Isolation of Quarantine, Release, In-Process, Finished Product, Packaged Product and Rejected areas.
- Support activities as assigned by QA Management to facilitate testing, qualification, system improvements and compliance [Change Controls, CAPA, Out of Specification (OOS)].
- Maintains safe and healthy work environment by following standards and procedures and complying with legal regulations.
- Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency.
- Responsible for the cleaning and sanitization of sampling area, as per written procedures.
- Work with other departments to plan and prioritize the review and release of materials.
- Ensure compliance with Standard Operating Procedures (SOPs), Forms, Batch Production Records, Protocols, as needed.
- Operate in compliance of cGMP, 21CFR and USP regulatory requirements.
- Other duties as assigned.
Essential Functions Statement
Reasonable Accommodations Statement
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
SKILLS & ABILITIES
- Bachelor’s or Associates degree preferred; quality control, quality assurance, or related experience can substitute. High school diploma required.
- Familiarity with AQL sampling preferred.
- Self-motivated, dependable, well organized, and able to communicate effectively and efficiently, both orally and in writing
- Must hold excellent problem-solving skills.
- Excellent attention to detail and capable of performing dependable, accurate work.
- Ability to perform general arithmetic.
- Basic computer knowledge.
- Ability to lift up to 25 lbs.
- Flexibility and ability to manage multiple and competing priorities.
- Ability to multi-task with strong sense of urgency; ability to meet deadlines.
Required reading, writing, and speaking fluently in English.
While performing the responsibilities of the job, the employee is required to talk and hear. The employee is required to sit, stand, walk, reach with arms and hands, lift objects, and use their hands and fingers to handler or feel. The employee is occasionally required to climb or balance, stoop, and kneel, crouch or crawl. Visions abilities required by the job include close vision. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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.