Job#: 1276856 Job Description: QA Operations Specialist I
Apex Systems is seeking a QA Operations Specialist I near Webster, TX for a contract project with a global leader in pharma, biotech and consumer health . The QA Operations Specialist I will assist with maintaining quality oversight of operational areas by working closely with operation personnel and performing various checks during manufacturing processes. Additionally, the QA Operations Specialist I will assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and the company's Standard Operating Procedures.
*If interested in the position, please send your resume to email@example.comResponsibilities
- Ensures compliance with all regulatory agency requirements and company specific regulations related to quality of product.
- Assist in the reviews of records to ensure they are complete, accurate and compliant with current Good Manufacturing Practices (cGMP) requirements.
- Reports errors, deficiencies, discrepancies and observations to management. May stop operations when product safety is or may be compromised.
- Performs Quality functions in classified areas, including checklists, aseptic intervention oversight, and line clearances.
- Works in collaboration with management team to prepare for the internal and external auditors.
- Ensures that SOPs are current and effective and that staff performs routine tasks according to SOP through direct observation.
- Monitors operational processes by performing product changeover/room clearance in changeover/rooming work-in-progress then reporting results to proper management.
- Assist with Root Cause assessment and suggests corrective action to prevent recurrence.
- Evaluates technology transfers associated with new products or processes.
- Willing to work flexible hours to support organizational needs.
- Bachelor's Degree with emphasis on science / life sciences
- 0 to 4 years relevant Quality Operations experience, preferably working within an FDA regulated manufacturing facility
- Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
- Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Ability to operate Microsoft Office software: Excel, Word, Outlook, and PowerPoint
- Demonstrated ability to work under aggressive timelines, demonstrated time management skills.
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 firstname.lastname@example.org