QA Specialist

DUTIES AND RESPONSIBILITIES:

• Performs and documents GLP, cGMP, and internal audits; audits documentation associated with drug substances and drug products, stability programs, complaints, and related systems.
• Prepares audit reports and performs follow-up to obtain resolutions that are compliant with regulations and satisfactory to all parties.
• Identifies in-house quality issues.
• Leads product nonconformance investigations.
• Prepares impact assessments for process and procedural deviations.
• Researches and assists in interpretation of regulations that are relevant to company’s operations.
• Maintains auditing schedules.
• Participates in vendor certification programs.
• Maintains quality assurance databases, reports, and files.
• Assists in performing audits of external raw material vendors, contractors, collaborators, and other relevant organizations as needed.
• Prepares, performs, and documents personnel training to ensure personnel have the appropriate training and understanding of QA systems.
• Performs timely review of batch production records; assures that batch records are complete, correct, and meet all pertinent documentation requirements.
• Assists in review of all supporting documentation including but not limited to area and equipment log books, cleaning logs, and environmental monitoring data.
• Assists in QA release of drug substances and drug products for distribution.
• Verifies product release status for other departments; completes all appropriate release checklists and certifications.
• Monitors and reviews validation projects.
• Assists with management reports; area clearances; analyses of quality-indicating data trends; preparation of annual product reviews; Quality Overall Summaries; investigation of deviations; corrective actions; variances; and product complaints; preparation and reconciliation of relevant portions of QA budget; preparation of SOPs, laboratory investigations, and training syllabi as needed.
• Performs equipment calibrations, maintenance, and repairs.
• Assists in qualifying new analytical procedures and instruments.
• Performs other related duties as assigned by management.

QUALIFICATIONS:

• Bachelor’s degree (B.S.) in chemistry, biology or equivalent
• Two to four years related experience or equivalent
• Strong knowledge of pharmaceutical manufacturing processes, computer and

     equipment validation, GMPs, and product/process validation.

• Ability to develop clear, concise, and timely oral and written reports.
• Experience with laboratory environment, equipment and safety procedures.
• Experience in research and development, including understanding of statistical

     analysis.

• Commitment to excellence and high standards
• Excellent written and oral communication skills
• Strong organizational, problem-solving, and analytical skills
• Ability to manage priorities and workflow
• Versatility, flexibility, and a willingness to work within constantly changing

     priorities with enthusiasm

• Acute attention to detail
• Demonstrated ability to plan and organize projects
• Ability to work independently and as a member of various teams and committees
• Proficient on [ MS Word, MS Excel, MSPowerpoint)
• Proven ability to handle multiple projects and meet deadlines
• Ability to work on complex projects with general direction and minimal guidance.
• Working knowledge of data collection, data analysis, evaluation, and scientific

     method.

• US Citizenship/Permanent Work Permit required