QA & QC Technical Specialist

Provide technical support for QA, and for QC and TS laboratories which can incorporate raw materials, in-process testing, stability protocol and testing, method development and validation, equipment validation (IQ, OQ, and PQ), calibration, and troubleshooting, in addition to Annual Reviews and Annual Product Review documentation according to Quality Assurance procedures. Accurately generate and document all work per written procedures and corporate policies.  Support management and peers in improving the efficiency and compliance status of the laboratories. Other duties as assigned.

• Encourages safety first in work practices via guidance from training sessions, chemical hygiene plan, MSDSs (Material Safety Data Sheets), and other technical literature and resources
• Troubleshoots, solves, and reports problems with laboratory equipment.
• Maintain the QC and TS laboratories to comply with cGMP and USAntibiotics’ standards of safety, quality, and cleanliness.
• Provides statistical support as required and develops content for annual product reviews, special studies, investigations, validation projects, regulatory submissions, etc.
• Assist with Annual Product Review (statistical analysis of stability data, release data, and other sections of the periodic review)
• Assist with preparing Annual Report content (summary of manufacturing changes which are led through Technical Services)
• Reviews (i.e., validates) analytical test results for other laboratory personnel, as trained and assigned.
• Maintains and manages the Master Calibration and PM schedule for the QC Laboratories, and supports/performs instrument qualifications, calibrations, and maintenance as needed and as trained, according to schedules and procedures, documenting all results.
• Performs satisfactorily on all analyst qualification studies, indicating technical proficiency, and may perform analytical testing as needed where qualified (ex: Stability testing)
• Supports analytical method validations or transfers as needed.
• Support any special studies as needed in accordance per protocols and direction of management. Prepares well-documented reports of results.
• Strictly follows written procedures in consistent fashion so as to minimize analytical variability.
• Suggests to area management any potential improvements, ideas or changes to methods and operations as appropriate for evaluation (any changes to be adopted will be implemented via the change control process).
• Interprets analytical results correctly, notifying supervision promptly of any situation that indicates analytical issues or product issues.
• Assists with technical writing as required, e.g., revision of analytical procedures, equipment related SOPs, results summaries, as required. Notifies management of any SOPs that may require revision and initiates change requests per written policy, providing sufficient evidence/documentation to support change request(s).
• Evaluates and utilizes state-of-the-art equipment, including automated systems and computerized systems to perform and document testing and meet the goals of improved performance, including reliability and efficiency.
• Assists the Quality unit in meeting goals, business objectives, and production plans.
• Propose ideas to management for operational changes in laboratory within constraints of policies and procedures to improve cGMP compliance, efficiency, cost, and performance and appropriately develops change controls for any that are to be progresses, as applicable.
• Carries out other departmental duties as deemed appropriate by Manager.
• Keeps current with technical and professional literature and compendia, attending technical discussions, and training opportunities.
• Assists QC Unit in conducting analytical failure investigations, as required, following all procedures.

• BS/BA degree in Chemistry (or related science) or equivalent related analytical experience
• Minimum two (2) years of analytical experience in pharmaceutical industry or related technical scientific work experience.
• Strong knowledge/experience of cGMPs in areas beyond QC laboratory.

Required Knowledge:

• Thorough understanding of analytical techniques, test methodology, method development, method validation and reporting for data integrity.
• Comprehensive skills related to chemical, instrumental, chromatographic analysis, Operational Excellence, statistical applications and tools
• Thorough understanding of equipment installation, validation, calibration, and troubleshooting, etc.
• Strong knowledge of cGMPs, USP and FDA’s laboratory related requirements

Skills/Abilities:

• Knowledgeable of a wide variety of laboratory equipment, testing procedures, GMP practices and maintain a safety conscious manner.
• Advanced computer skills.
• Appropriate interpersonal (teamwork) and leadership skills
• Strong verbal communication skills and technical writing skills.
• Ability to prioritize and decide appropriate course of actions routinely.
• Ability to implement decisions per instructions and guidance.
• Ability to recognize possible compliance, technical, or safety-related issues and notify management promptly. Ability to suggest appropriate corrective and/or preventive action(s) and assist with implementation, as needed.
• Ability to work in a multi-disciplinary team environment
• Demonstrate visual acuity per SOP requirements

 

Jackson Healthcare and its family of companies are an EEO/AA Employer. All qualified applicants will receive consideration for employment without regard to race,color,religion,sexual orientation,gender,gender identity and expression,national origin,age,disability or protected veteran status. We celebrate diversity and are committed to creating an inclusive environment for all of our associates.