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Full-timeDescriptionAnalytical QA Associate is responsible of providing analytical data review of QA Documents, support the development to ensure compliance with cGMP, FDA, Internal Policies, Procedures and Specifications. Responsible for the safe and efficient execution of job duties.Principle Accountabilities
JOB DUTIES & RESPONSIBILITIES
- Part of analytical data review team according to the priorities.
- Perform Data Review of Raw Material, Finished Product, Packaging Materials, In-Process, Finished Product, outside testing data, water testing data, Stability Samples, cleaning validation, swab analysis, equipment calibrations, IQ, OQ, PQ, Method Validations, Verifications of Drug Substance and Drug Product and cleaning methods (Electronic data, Notebooks, logbooks, Reports, and electronic sign off's) and notify Laboratory management or designee for any deviations, Out of Trend, extraneous peaks or out of specification result
- Perform product review for analytical data.
- Responsible for ensuring and performing Data review of Analytical R&D, FDA deficiencies, PDR reports, ANDA submission data related to analytical area.
- Ensure logbook is up to date of all instruments in quality control or analytical laboratory.
- Standard and accurate usage logbooks (USP, In-house, secondary, any other pharmacopoeia) and column logbooks.
- Review the data to comply with Laboratory Procedures, Test method, Protocols, GLP, GDP and cGMP and work with Laboratory personnel for any corrections and promote cGMP culture.
- Responsible to ensure the documentation is completed, any discrepancy found during the review shall be corrected before data sign-off.
- Any additional activity as assigned by the Supervisor.
Management Responsibility Reports to
AQA Manager/Associate Manager
Internal/External Contacts
NA
Knowledge & Skills
- Knowledge of 21CFR, ICH, USP and other applicable regulatory requirements and standards.
- Manage and host Regulatory inspections.
- Ability to maintain integrity and honesty at all times.
- Ability to communicate and lead with transparency.
- Lead department for optimal performance and set course for future improvements.
- Accountable for performance and results of department.
Experience & Education
- Requires minimum BA/BS in Pharmacy, Biochemistry, Chemistry or related field with 3+ years of experience in the biotech or pharmaceutical industry. Management experience in Quality Control required and MS/MA preferable.
Physical Requirements/Working Environment
NA
Travel
Minimal
Disclaimer
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.
Requirements
Required Qualifications:
- Quality assurance within Pharmaceutical Industry: 2 years highly preferred
- Manufacturing: 2 years (Preferred)
- Document management: 2 years (Preferred)
Knowledge & Skills
- cGMP compliance within the pharmaceutical manufacturing industry.
- Writing and maintaining cGMP documentation.
- Analyze data/information and resolve complex issues.
- Verbal and written communication skills.
- Work and communicate with cross-functional teams.
- Multiple priorities and re-prioritize tasks.
Experience & Education
- At least 2 -3 years of experience in a quality assurance role in a cGMP-regulated environment.
- A college Degree preferably in sciences (i.e., Biology, Chemistry etc.), or related discipline
