Incoming QC Technician

Sagent Pharmaceuticals – Raleigh, NC

Incoming QC Technician

This position reports to the QC Manager and has no direct reports. The individual holding this position is responsible for the physical incoming quality control testing to ensure components are tested and meet the acceptable limits per the approved specifications and for the sampling and of incoming raw materials.

Success of this role would be measured primarily by the following:

Responsibilities include:

• Responsible for the sampling, inspection and performing dimensional measurements for incoming components (Vials, Stoppers and Seals).
• Will require routine use of calipers for performing measurements of components
• Will require sampling of incoming raw materials in classified spaces (Grade C and D). Entry in the classified spaces will require gowning. Sampling will require the occasionally lifting up to 50 pounds and carrying less than 25 lbs.
• Standing, walking, bending over, and repetitive use of legs are done occasionally
• May require shipping and tracking of materials sent off site for testing
• Incoming quality control will perform physical testing to ensure components meet the acceptable limits per the approved specifications. This includes sampling, defect inspection and dimensional measurements of components per the approved specification.
• Responsible for the sampling, helping to arranging shipping of samples to contract testing labs or submitting the Raleigh Quality Control Laboratories for testing.
• Communicates with Logistics Management, Quality Assurance, Quality Control and Technical Transfer departments pertaining to the status of incoming materials and potential quality concerns.
• Assists in drafting of SOPs pertaining to IQC Group.
• Ensure work area and equipment is cleaned and well maintained prior to and following each operation
• Initiate or Assist in the completion of OOS investigations, Deviations and CAPAs.
• Comply with cGMPs through adherence to SOPs and company policies relating to quality, safety, housekeeping and cost effectiveness.
• Other duties as specified by Manager.
• Work with internal and external stakeholders in a flexible team-oriented approach.
• Strong interpersonal skills including verbal and written communication.
• Strong attention to detail.
• Ability to manage multiple activities in a fast-paced, changing team environment essential for a generic pharma company.
• Solid computer skills, data analysis, and presentation skills to the QC team.
• Handle routinely hazardous chemicals including acids, bases and flammable liquids/gases

Candidate Requirements:

• High school diploma or equivalent, Associates Degree or higher preferred.
• Knowledge of cGMP’s and ability to apply analytical reasoning and root cause analysis to solve problems.
• Demonstrated ability to read, understand, interpret and apply technical writing and instructions.
• Strong interpersonal communication skills required – verbal and written.
• Must have initiative, self-starter, and multi-task-oriented skills.

Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.

Sagent Pharmaceuticals is an EEO/AA employer and does not discriminate on the basis of race, color, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation.