SENIOR QA/C SPECIALIST

The Senior QA/QC Specialist is responsible for assisting in the continued development and improvement of product quality procedures to ensure compliance with FDA cGMP CFR 111, California Proposition 65, FDA OTC, and other regulations. Assures consistent quality of production by developing and enforcing good manufacturing practice (GMP) systems; validating processes; and providing documentation.

Essential Functions:

Prepare and maintain all Standard Operating Procedure (SOP) to meet cGMP requirements.
Prepare and maintain specifications for all raw materials & finished products.
Develop and maintain QA policy and QC plans.
Review and manage product labels.
Design/update the forms of production batch records to meet GMP requirements.
Instruct Process Control staff to prepare production batch records and MMR.
Review production batch record and proper filing.
Perform quarterly internal inspections for Production and Warehouse facilities and host meetings to notify related parties.
Perform monthly GMP training for Production and Warehouse personnel.
Prepare and issue COA for customers with authorized signatures.
Manage calibration schedule for production and lab equipment.
Investigate and respond to customer’s claims in a timely manner.
Present product defect trend analysis to the management team.
Present documents and answer questions to the auditors during FDA, GMP & Food Safety inspections.
Develop and maintain Supplier questionnaire.
Travel overseas for foreign supplier verification (FSVP).

Generate periodic reports of GMP issues for company Executives.
Provide support to all departments and miscellaneous projects as needed.
Other QA/QC-related duties as assigned.

Physical Requirements:

Vision, hearing, writing, and speaking to meet performance standards.
Standing, sitting, walking, and bending for extended periods.
Lift and/or move up to 25 pounds on an occasional basis.

Equipment Used:

Computer
Lab testing equipment
Multi-line telephone
Copier/ Fax machine

Work Environment:

Requires the ability to work in an environment that contains fumes, dust, odors, noise, chemicals, temperature variations, and varying degrees of ventilation.

Qualifications:

Requires a Bachelor of Science degree, in analytical chemistry, and biochemistry, preferably from a 4-year college or university.
Ability to process improvement, analyze information, strategic planning, verbal communication, informing others, quality engineering, emphasizing excellence, pharmacology, attention to detail, thoroughness, and dealing with complexity.
Five years of related experience (preferably in the Dietary Supplement or Pharmaceutical industry.)
Familiar with standard concepts, practices, and procedures in related areas.
Ability to utilize experience and judgment to plan and accomplish goals.
Ability to read, write, speak, and comprehend English.
Excellent skills in MS Word, Excel, and PowerPoint.
Knowledge of Inventory and Quality Control software.