Quality Control Specialist I

Full Job Description

Job Title: Quality Control Specialist I

Job Description:

ImmunoReagents, Inc. is a small woman-owned biotechnology company located in Raleigh, North Carolina that focuses on the production and conjugation of polyclonal antibodies and reagents used in the life sciences and in vitro diagnostic markets. Products are manufactured following cGMP guidelines and ISO QSR systems requirements. The ideal candidate will be able to thrive in a dynamic, fast-paced manufacturing environment under tight production deadlines. Qualified candidates must possess the ability to follow written instructions without deviation. Must possess excellent attention to detail and utilize good documentation practices. Must be a team player and work well within a small group environment under the supervision of senior staff members and laboratory management. The Quality Control Specialist I will be responsible for testing of raw materials, in-process, and finished goods and report test results to Quality Assurance. He or she should have a basic understanding of the testing procedures to help troubleshoot possible manufacturing or QC issues.

Note: This position is not eligible for relocation expenses.

Required:

· Associates or Degree in a scientific discipline: or,

· Up to 2 years of experience in laboratory environment

Preferred:

· Bachelor’s Degree in Biology, Biomanufacturing, Biochemistry or related field

· At least 1 year of experience in a cGMP environment

· Experience in SDS-PAGE, HPLC and immunoassays a plus

· Excellent pipetting technique

Quality Control Responsibilities:

· Samples to be tested include but are not limited to: R & D samples, raw materials, and finished goods including antibodies and antibody conjugates.

· Proficient in SDS-PAGE, HPLC, IEP and ELISA formats used for product testing.

· Schedule work flow to ensure timely release of materials from QC. Materials will include in-process material, final product, raw material testing as well as R&D projects.

· Work with Manufacturing/Sales/Process Development/Quality Assurance to prioritize product testing; know when material will be received and when product is due to ship. Also report status of all testing to the above groups in a timely manner.

· Notify Quality Assurance and Manufacturing when unexpected results occur.

· Maintain all necessary reagents and materials needed for Quality Control Testing.

· Maintain all procedures and processes under ISO 9001 guidelines, including equipment maintenance and calibration.

· Aid in testing and design of new products or R&D projects.

· Maintain all necessary reagents and materials needed for Quality Control assays.

· Operate under ISO 9001 quality systems requirements and cGMP guidelines.

Additional Responsibilities:

· Assist in day to day operations of the Company as needed. Examples include but are not limited to, assisting in pulling products for orders, labeling vials, washing dishes, lab maintenance, setting up emergency backup, etc.

Position NOT eligible for relocation expense reimbursement

General Requirements:

· Must be proficient with Microsoft Word/Excel

· Must be a team player

· Must be an effective communicator - both written and oral

· Must be detailed oriented

· ISO/cGMP experience a plus

Physical Demands: The ratings in the chart below indicate the percentage of time spent on each of the essential physical requirements.

Seldom—Less than 25% = 1

Occasional—25-50% = 2

Often—51-75% = 3

Very Frequent—76 % and above = 4

Ratings

Essential Physical Requirements

2 Ability to work at a desk, conference table or in meetings of various configurations.

2 Ability to stand for extended periods of time.

3 Ability to sit for extended periods of time.

4 Ability to see for purposes of reading printed matter.

3 Ability to hear and understand speech at normal levels.

4 Ability to communicate so others will be able to clearly understand a normal conversation.

2 Ability to bend, twist and work in confined spaces.

2 Ability to lift 50 pounds.

2 Ability to carry 50 pounds.

3 Ability to operate office equipment.

2 Ability to reach in all directions.

1 Ability to climb stairways and/or ladders.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Paid time off
• Retirement plan
• Vision insurance

Education:

• Associate (Preferred)

Experience:

• Laboratory: 1 year (Preferred)

Work Location: In person