Incoming Materials Specialist II, QA

Description

 SUMMARY: 

The Incoming Materials Specialist II is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC, in Piscataway, NJ. This position is responsible for managing the Quality Control (QC) testing of Raw Material and Critical Material. The incumbent must be an independent performer with prior experience in managing Raw Material/Component Testing functions as well as test specifications management in a cGMP facility in the pharmaceutical or medical device industry.

Essential Duties and Responsibilities:

· Perform Inspection, sampling and testing where applicable on all incoming raw materials, packaging components and returned goods following detailed written procedures. 

· Work with other departments to plan and prioritize the review and release of Materials. 

· Ability to work independently or in teams both within department and cross-functionally. 

· Must be able to organize, plan and deliver assigned tasks to bring projects to completion.

· Perform review and release of Raw Materials and Critical Materials in a timely manner.

· Preparation of samples for chemical and microbiological (where required) analysis and delivering them to the QC lab. 

· Inspection and test of packaging components utilizing various measuring devices such as scales, micrometers, and height gauges to determine conformance to specifications. 

· Maintaining detailed records of sampling, inspections, and testing activities. 

· Assigning and verification of expiry date and retest date for all the GMP raw materials through vendor COA and/or in-house COA. 

· Inspects and approves incoming materials by confirming specifications, conducting visual and measurement tests, and rejecting and returning unacceptable materials.

· Documents inspection results by completing reports and logs, summarizes re-work and waste, and inputs data into quality system.

· Compliance of Warehouse areas in terms of Isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas. 

· Maintains safe and healthy work environment by following standards and procedures and complying with legal regulations.

· Responsible for the cleaning and sanitization of ISO 7 area and ISO 5 Laminar flow hood, as per written procedures. 

· Ensures smooth flow of raw material, critical material testing through routine follow-up with internal and external laboratories. 

· Responsible to coordinate with the quality compliance department to address concerns regarding contract laboratories and/or external vendors. 

· Participates in the creation/revision of documents for incoming materials to reflect the change in regulatory guideline (i.e., CFR Title 21, USP/NF). 

· Perform other duties and responsibilities as delegated by Quality Management.

Requirements

  PREREQUISITES:

Education:

· Bachelor’s Degree in Analytical Chemistry, Chemistry, Biochemistry, microbiology, or related field.

Experience: 

· 3+ years related experience in a relevant cGMP environment is required.

· Prior experience in Raw material release laboratory with hands on testing experience preferable. 

· Understanding of United States Pharmacopeia (USP) general chapters and testing requirements.

· Demonstrate accountability, attention to detail and time management. 

SPECIALIZED KNOWLEDGE AND SKILLS: 

· Must read, write, speak English, and communicate well.

· Requires the ability to interact with suppliers and assist with issues in relation of incoming raw materials

· Scientific understanding of raw material tests and test procedures

Computer and/or Technical Skills:

· Operation and understanding of word processing, spreadsheets, and data management software.

· Presentation of data and reports to small/large groups is part of the job.

WORK ENVIRONMENT AND PHYSICAL DEMANDS: 

General Work Environment:

• Laboratory and controlled cleanroom space.
• Must be able to wear proper PPE as per written procedure and/or external guidance (i.e., NIOSH, OSHA).

Noise:

• Standard noise levels expected with laboratory and manufacturing equipment.

Standing/Lifting:

• Extended periods of standing and walking while working in the manufacturing and sampling areas
• Must be able to lift 15 pounds of free-weight and/or push 150 pounds on wheels for short distances.

Visual:

• No special requirements

Stress:

• High-paced demanding environment to meet drug product manufacturing schedules

Travel:

• Travel not generally expected.

Kashiv Biosciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Kashiv Biosciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation, and training.