Quality Assurance (QA) Specialist I, II, & III

Essential Duties & Responsibilities:

Manage a broad spectrum of projects to support the needs of Quality Management.
Issue, assembly, and review of documentation supporting batch, laboratory, warehouse, metrology, engineering, and validation activities, to ensure complete and in compliance with company policies and procedures and cGMP requirements. Quality system documentation to include SOPs, deviation/investigation reports, equipment/system qualification protocols and reports, change controls, as well as document control activities (training records entries, logbook issuances, logbook archival, etc.)
Interface with cross-functional departments. Perform quality assurance walk-through audits of manufacturing, laboratory, and warehouse areas to ensure compliance with CGMPs and company procedures.
Quality support of environmental/quality monitoring and release of controlled systems and environments. Support includes data review for release and support of investigation activities.
Assist and provide input as part of a project team to resolve quality and manufacturing issues and identify and implement corrective and preventive actions in a timely manner.
Perform Raw Material, water, and gas sampling, In-process and Finish Product sampling, and coordinate submission of samples to QC analysis.
Receiving external samples and logging into the internal quality system
Quality release of raw materials and finished products.
Provide backup for other Quality Assurance Specialist responsibilities. Perform other duties and responsibilities as delegated by Quality Management.
Ensure adherence to GMP good documentation practices
Complies with all company policies and standards
Requirements

Position Requirements and Qualifications

Minimum Qualifications:

Education:

A 4-year Bachelor’s degree, preferably in a science or engineering discipline
Experience:

Previous experience for QA I (0 to 2 years or more), QA II (2 to 5 years or more), and QA III (5 plus years) in a cGMP biologics/biosimilars manufacturing laboratory environment is required.
Working knowledge of cGMP regulations (21 CFR210/211/820) is desired.
Working knowledge of Deviation, CAPA, Change Control, and Validation/Qualification (IQ/OQ/PQ) is desired.
Certification from professional organizations such as ASQ and ISPE is desired but not required.
Preferred Qualifications:

SPECIALIZED KNOWLEDGE AND SKILLS:

Good communication skills, both written and verbal.
Good organizational skills and detail-oriented. Must be able to effectively manage time to complete assignments.
Excellent computer skills in Microsoft Office applications.
Ability to work independently or in teams both within the department and cross-functionally. Must be able to organize, plan, and manage assigned tasks to bring projects to completion.
Direct experience in manufacturing QA support (sampling, room/line clearance, cleaning verification) preferred
Understand the requirements and procedures related to document control and Quality Assurance.
Experience in GMP document control
Must be able to utilize technical information appropriately to ensure documents produced are consistently clear, concise, accurate, and complete.