Quality Specialist

This position is responsible for providing Quality inspection support to all areas of production. Primary responsibilities include review of controlled documents for accuracy, completeness and in accordance with cGMP, related company SOPs, State and Federal laws prior to and including testing, and release of product. This is a high-energy position that requires the ability to organize, prioritize and work with a sense of urgency and positive attitude.

• Will participate in inspection and release of incoming materials, line clearance and in-process inspections in the production area, and maintaining lot history records.
• Will work closely with operators and supervisors to improve processes in various production areas.

· Supports the training of personnel to applicable quality policies and procedures, and work instructions.

· Responsible to disposition (approve/reject) all finished product and review production records to assure that no error has occurred.

· Report errors found in the respective batch record to manufacturing and ensure correction and/or resolution.

· Generation of Certificates of Analysis to be included with shipments of the finished product.

· Responsible for controlling and filing (by lot number and date) all original production records.

· Apply good documentation (GDP) and understanding of good manufacturing practices (cGMP) to ensure documents meet the acceptance criteria.

· Ensure QA test samples are forwarded to the lab for testing and review test results for acceptability.

· Ability to identify a problem and offer a resolution in order to avoid major issues.

· Work independently and ensure all documents tied to product release are prioritized appropriately.

• Exceptional attention to detail and ability to maintain consistency. Can schedule and organize tasks in an orderly and neat fashion.

· Complete special projects as assigned by Quality Management.

· Display a willingness to learn and assist in other department activities when needed.

· This position requires lifting and manipulation of large packages.

:

· Minimum of 3 years of progressive experience in Quality Assurance within cGMP environment, preferably cosmetics, pharmaceuticals and/or medical device industry.

· Knowledge and use of Outlook, Word, and Excel.

· Knowledge and use of QMS software a plus.

Job Type: Full-time

Pay: $40,000.00 - $60,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 1 year
• 2 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person
• Office

Ability to Relocate:

• Rosenberg, TX 77471: Relocate before starting work (Required)

Work Location: In person