QA Associate

Job Overview:

We are seeking a detail-oriented and analytical Quality Assurance Analyst to join our team. The Quality Assurance Analyst will be responsible for ensuring that our products meet the highest quality standards through meticulous testing and analysis. This role requires strong attention to detail, excellent problem-solving skills, and a thorough understanding of quality assurance processes. Ensure individual compliance with FDA regulations, cGMPs, and all other applicable requirements, applicable department programs to include training, documentation, standard operating procedures, and Kesin Pharma Corporation policies.

Responsibilities:

• Ensure compliance with all current Good Manufacturing Practices (cGMPs), SOPs, and facility safety standards as related to the equipment, work area, and personnel.

• Assist QA in-process personnel and functional processes.

• Implementation, review, revision and archival of controlled documents.

• Collaborate and assist in the training curriculum, supervising, developing, and supporting staff (QA Associates) that are responsible for reviews of quality system records.

• Responsible for reporting issues related to cleanliness/repair/maintenance to Operations or Facilities Management and overseeing quality approval before continued use of the affected area or item.

• Preparation and review of site Quality Documentation, including SOPs, Policies, Analytical Worksheets, Master Manufacturing Documents and Material Specifications, in compliance with site procedures and regulatory requirements.

• Reviews, performs sampling, and disposition of product at various stages for: all received bulk materials and components, raw materials, in-process material, and finished goods.

• Ensures that periodic cleaning validations and production equipment validations /re-assessments are performed and documented within the timeframes specified.

• Responsible for retain/reserve sample management.

• Provides QA oversight and support for warehouse operations.

• Assists with the collection of stability samples or special request samples for each lot.

• Reviews Manufacturing, Packaging, and Quality Operation processes and GMP documentation.

• Executes reviews of batch records and release of finished products.

• Conducts investigations/deviations/CAPAs of issues related to products.

• Reviews or prepares Master Batch Records, Master Packaging Records (where applicable), Finished Product Specifications, QC Testing Specifications for approval by QA Management.

• Prepares Change Controls and executes Validation Protocol Activities.

• Master Labeling review and distribution.

• Initiate and review Finished Product C of A’s (if applicable).

• Provides periodic key performance reports to Senior Management as required.

• Assists Director in conducting internal and 3rd party external compliance audits.

• Verifies and approves QC test results and/or QA documentation.

• Leads and prepares documentation of investigation activities, root cause analysis, deviations, complaints, and develops CAPA plans for approval by QA Management.

• Perform other duties as assigned by Management.

Requirements:

• Bachelor's degree in a relevant field or equivalent work experience

• Proven experience in quality assurance or a related role

• Strong knowledge of QA/QC (Quality Assurance/Quality Control) principles and methodologies

• Ability to analyze complex data sets and identify patterns or anomalies

• Excellent attention to detail and problem-solving skill

• Able to stand, bend, and stoop for extended periods of time and ability to lift 45 lbs. unassisted.

• The facility is in two neighboring buildings, and routine movement between buildings is required.

• Strong written and verbal communication skills

• Proficiency in using software applications for data analysis and reporting

Additional Skills and Qualifications

• Previous experience in pharmaceutical GMP environment.

• Knowledge of FDA regulations related to GMP.

• Thorough knowledge of quality control/assurance and/or operations is preferred. Must have experience of pharmaceutical in-process stages.

• Must have a good interpersonal and communication skill in English, understand both oral and written instructions, and be detail oriented.

• Must possess the ability to manage multiple projects with competing deadlines.

• General computer knowledge of basic software, i.e., Microsoft Word, Excel, email communication.

We offer competitive compensation packages, including benefits such as health insurance, retirement plans, and paid time off. Join our team of dedicated professionals committed to delivering high-quality products to our customers.

Job Type: Full-time

Pay: $20.00 - $22.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Experience level:

• 2 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person
• Manufacturing facility
• Office
• Warehouse

Ability to Relocate:

• Oldsmar, FL 34677: Relocate before starting work (Required)

Work Location: In person

Salary : $20 - $22