The Quality Assurance Specialist is a member of the Quality Assurance team reporting directly to the Head of Quality. This position is responsible for maintaining quality oversight for all operational areas.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Ensures compliance with all regulatory agency requirements and company specific regulations related to quality of product.
- Reviews records to ensure they are complete, accurate and compliant with current Good Manufacturing Practices (cGMP) requirements. Records include batch records and other documents involved in the manufacture of drug product.
- 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.
- Develops new material specifications upon request; revise existing material specifications when changes are necessary.
- Works in collaboration with management team to prepare for internal and external auditors. Assists with timely closure of audit observations.
- Apply quality compliance theories and principles to independently address a variety of issues of moderate scope.
- Work independently, with support through management and mentoring.
- Collaborate and facilitate with functional groups under supervision providing guidance on controlled documents (content, quality, and document lifecycle), identifying gaps, addressing documentation needs, developing training curriculums and suggesting process improvements.
- Conducts monthly/quarterly quality assurance audits for critical logbooks and required inspections of classified areas.
- Initiates standard operating procedure (SOP) revisions as needed to support continuous improvement.
- 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 inspections and auditing work-in-progress then reporting results to proper management.
- Mentors and trains junior staff on GMP’s and training development.
Supports operational departments as needed to assure customer and regulatory requirements are met.
- Performs Root Cause assessment and suggests corrective action to prevent recurrence.
- Willing to work flexible hours to support organizational needs.
- Bachelor’s Degree with emphasis on science / life sciences.
- 5 to 7 years relevant Quality Systems 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 effectively present information to top management.
- 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.
- Demonstrated excellent oral and written communication skills
- Demonstrated solid training and presentation/facilitation skills
- Demonstrated analytical, critical thinking and decision-making skills
- Demonstrated ability to work effectively and independently
- Demonstrated knowledge of procedures, documentation practices, GMP’s and regulations associated with the manufacture of bio-pharmaceuticals.
APPLY TO: firstname.lastname@example.org.