Job description

To apply directly to this position please visit: https://signaturebiologics.hirecentric.com/jobs/223597-47231.html

Signature Biologics is a biopharmaceutical company developing novel cellular and biologics to provide medical relief to patients with unmet clinical needs. At Signature Biologics, we have decades of experience in human perinatal biologics both domestically and internationally.

The Quality Control Technician focuses on verifying the quality attributes of the intermediate and final products of a manufacturing process to make sure that meets the required specifications or quality standards. Supports Quality Assurance activities while being knowledgeable about manufacturing processes.

Essential Duties and Responsibilities:

Perform related duties as assigned by Associate Director of Quality and Chief Manufacturing Officer.

Routine Testing of Reagents, Intermediate Product and Final Product:

• Responsible for the daily Quality Control Laboratory functions, including:
• Verify the suitability of reagents used for quality testing or manufacturing.
• Perform quality control testing related to release criteria of intermediate and final product according to established instructions and procedures.
• Timely documentation of the testing activities following Good Documentation Practices.
• Supports the in-process testing for Manufacturing.
• Works the testing schedule with the Release Criteria Coordinator to support timely release of final product.
• Identifies out-of-specification product, including placing product on hold, proper identification, and segregation of nonconforming product, initiating deviation reports, and participating in investigations.
• Routine calibration of laboratory equipment.
• Communicate and coordinate inventory needs for test materials and supplies.
• Ensure the laboratory is kept in a safe working environment and in compliance with OSHA and other laboratory safety standards.
• Maintain a clean work environment with regards to cleaning schedules and good housekeeping standards.

Testing for Validation Purposes:

• Execution of validation protocols ensuring that protocols are followed, and samples pulled and labeled accurately for testing.
• Review and verify executed protocols to assure that all requirements are met prior to reporting.
• Train personnel on validation protocols to be executed.
• Provides support to manufacturing and R&D including participation in product/process development trials, carrying out new types of raw material and product characterization/performance testing.
• Supports data collection activities by entering information into various databases and spreadsheets.

Education and/or Work Experience Requirements:

• Bachelor’s degree in Biology or Life Sciences required.
• 1-2 years experience performing quality control testing. Strongly prefer experience performing ELISA, flow cytometry, basic cell culture.
• Excellent verbal and written communication skills, including ability to effectively communicate with personnel from different departments.
• Excellent computer proficiency (MS Office – Word, Excel and Outlook)
• Must be able to work under pressure and meet deadlines, while maintaining a positive attitude and providing exemplary work product.
• Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices.
• Must understand global metric standard.

Physical Requirements:

• Must be able to lift, carry, and move up to 50 lbs.

Job Type: Full-time

Pay: $20.00 - $22.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Irving, TX 75063: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Based on the job description, why do you believe you are a competitive candidate for this position?

Education:

• Bachelor's (Preferred)

Experience:

• Quality Control Testing: 1 year (Preferred)
• ELISA: 1 year (Preferred)
• Cell culture: 1 year (Preferred)
• Flow cytometry: 1 year (Preferred)

Shift availability:

• Day Shift (Required)

Work Location: In person

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