Job DescriptionJob #: 1027803
Seeking a QA Specialist within the biotech/pharma industry!
- Performs a variety of activities to ensure compliance with applicable regulatory requirements.
- Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
- Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues.
- Works with operating entities with guidance from senior colleagues to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- May support in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
- Assist lead/coordinator with investigations and corrective and preventive action (CAPA) relating to manufactured products.
- May work with Research and Development during new product start-ups, with guidance from senior colleagues.
- Normally receives general instruction on routine work, detailed instructions on new assignments.
- Previous quality experience within the pharmaceutical or biotech industry
- Knowledge of cGMPs/GMPs
- Experience with investigations and/or corrective and preventive action (CAPA)
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.