Quality Control Analytical Development Manager Jobs

Job Location: Miramar, FL 33025
Salary Range: $75,000.00 - $80,000.00
Shift: Day

Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide.

This position is responsible for one or more of the following activities in the Quality Control Department: testing of in-process samples, final products, raw materials, components, microbial, and stability program samples. Administers all computerized quality systems in the lab including chromatographic data systems. Supports process validation activities. Supervises method transfers and supports method validation for analytical development. Maintains systems for cGMP compliance.

• Supervises quality control analysts and ensures their training and annual review.
• Allocates testing schedules to ensure timely release of analytical results to meet production and stability schedules.
• Approves data packages and release of analytical results.
• Maintains thorough understanding of all Quality Control STPs, SOPs and data acquisition systems.
• Initiates, reviews, and refines Quality Control STPs, specifications, and SOPs.
• Works with production managers to meet manufacturing needs.
• Works with Quality Assurance and Technical Services for all Process Validation Projects and compliance issues.
• Creates and reviews protocols/reports, including instrument calibrations, IQ/OQ/PQ.
• Authors, reviews, supports and supervises laboratory investigations.
• Coordinates and executes method validations and method transfer from/to Quality Control.
• Maintains a technical expertise in analytical laboratory instrumentation.
• May be assigned to administer the stability program for non-commercial and commercial products. This includes but not limited to: creating study protocols and reports, writing annual stability reports; evaluating stability data; working with off-site contractors to complete stability testing, monitoring stability chambers, coordinating the stability testing as per protocols and informing management of any stability failure.
• Recruits, trains, develops and manages effectively the ongoing performance of their direct reports, including:
  • Ensuring all Job Descriptions for direct reports are periodically reviewed, signed and stored according to our job description processes;
  • Reviewing and updating development plans for all direct reports, ensuring that all direct reports are properly trained and qualified according to our Training and Employee Qualification Enterprise Policy;
  • Effectively managing performance for direct reports according to the Performance Management Program;
  • Attracting and retaining talent based on our talent management framework;
  • Scheduling regular one-on-one meetings, probationary performance reviews and mid-year performance discussions;
  • Providing regular coaching, feedback and recognition based on the expected behaviors, job description and performance on objectives; and
  • Responsible to ensure compliance of team members with the Business Ethics and Compliance Program, Quality procedures, Safety and Environment policies, and HR policies.
• Works as a member of a team to achieve all outcomes; leads with a mindset that respects all cultural dimensions.
• Performs all work in accordance with the Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements; delivers work in support of the Values of Collaboration, Courage, Perseverance, and Passion.
• All other duties as assigned.

Education

Bachelor's degree (B.S.) in chemistry or related field or Master's degree (M.S.) in chemistry.

• Hands-on experience on HPLCs, GCs, Dissolution Apparatus, Balances, Spectrophotometers, Autoclaves, Laminar Flow Hoods, Stability Chambers, Incubators and Physical Testing Instruments (for pH, adhesion, peel, etc).
• Strong knowledge of chromatographic data management systems (i.e., Empower). Knowledge of the Stability Programs and current regulations. Experience with TrackWise and LIMS systems.
• FDA, cGMPs, and SOPs related to job requirements.
• Mathematical Skills: Ability to comprehend and apply principles of basic mathematics and statistical theory; ability to work with concepts such as limits, ranges, and numerical specifications.
• Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions; ability to interpret technical instructions and deal with abstract and concrete variables; strong troubleshooting and analytical skills; ability to conduct unbiased, scientifically sound laboratory investigations in a timely manner.
• Language Skills: Ability to read, analyze, and interpret scientific and technical journals, Pharmacopoeias, specifications, SOPs, and standard testing procedures; ability to write reports and procedures; ability to present information to management and other groups.

• B.S. degree + 7-10 years of progressively related experience and a minimum of 3 years as a Senior QC-Analyst or higher supervisory related experience.
• M.S. degree + 5-7 years of progressively related experience and a minimum of 2 years as a Senior QC-Analyst or higher supervisory related experience.