Qa Analyst I Jobs

The Quality Assurance (QA) Analyst I, under direct supervision, will be responsible for assisting with the review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting with product related activities; Assisting with Quality audit functions; Identifying process and Quality System improvements;
External US
Essential Functions:

• Review of vendor, supplier, contract laboratory audit questionnaires
• Standard Operating Procedures
• Assist in Quality audits to include, but not limited to:
• Audit of equipment logbooks
• Data Reports
• Corrective Action/Preventive Action Plans
• Audit of lab notebooks
• Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
• All other duties as needed.
• Assist with inspection of final product containers and review and/or approval of executed process records and data
• Assist with review of basic documentation to include, but not limited to:
• Assist with review of internal Quality policies, procedures and reports

Required Skills & Abilities:

• All candidates will have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products
• Ability to set personal performance goals and provide input to departmental objectives
• Ability to adapt to frequent and rapid changes in the work environment and allocate, adjust and optimize time accordingly
• Ability to work independently and establish work priorities to meet targets and timelines
• Excellent written and oral communication skills
• Proficient in Microsoft Office
• Excellent organizational, analytical, data review and report writing skills

Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:

• Experience prolonged sitting, some bending, stooping and stretching.
• Lifting up to 25 pounds on occasion.
• Attendance is mandatory.
• Ability to wear restrictive gowning for extended periods of time during periods of prolonged standing.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.

Qualifications:

• Bachelor’s degree in a related science concentration with some experience in Quality Assurance supporting pharmaceutical or biotechnology products: OR
• Associate degree in a related science concentration with 2 years of experience in Quality Assurance supporting pharmaceutical or biotechnology products

Preferred Qualifications:

• ASQ Certification
• Knowledge of GMP/GLP regulations

We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please e-mail [email protected] or call 979-431-3500.