Company Overview
Headquartered in Pomona, California, Med-Pharmex, Inc. is among the leading developers and manufacturers of generic veterinary pharmaceutical products in the U.S. The Company markets over 25 FDA-approved products, all manufactured in one of its three FDA-approved, Pomona-based facilities, with multiple drug delivery systems such as injectables, suspensions, oral solutions, sprays, ointments, creams, pastes, and powders. Utilizing its expertise and experience in pharmaceutical product development in a cGMP environment, the Company’s strength lies in its ability to continually innovate and develop products with high barrier entry, successfully navigate FDA regulatory requirements, and bring quality generic drug products to the veterinary market.
Job Purpose
Responsible for all analytical activities relating to Quality Control, including but not limited to; routine release analysis of intermediate samples (bulks) for finished product, stability studies and process validation analysis, ensuring all areas are executed within a timely manner.
Provides leadership to the quality control dept at Med-Pharmex. Reporting into the QC Director, Chemistry you will further establish culture and practices consistent with cGMP, cGLP and Health & Safety compliance; whist attaining the required throughput. Analyse/trend data, assess information and generate reports/metrics in order to provide accurate and appropriate responses and to identify potential risks and gaps.
Key Responsibilities
- Serve as a subject matter expert (SME) for QC Chemistry on finished product release, stability, raw material, reserve sample and container closure testing and sample management.
- Support QC Chemistry analyst training and development programs. Guide continuous analyst training on laboratory techniques, GDP, laboratory cleanliness and continuous improvement.
- Provide support to QC Chemistry laboratory Leads in guiding and assessing laboratory sample scheduling priorities.
- Assist QC Compliance in laboratory investigations as an SME and reviewer for Out-of-Specification, Out of Trend and Deviation investigations.
- Ensure the laboratory follows current good documentation practices and adheres to laboratory procedures.
- Approve/Review direct reports payroll hours and vacation requests.
- Serve as a subject matter expert (SME) for QC Chemistry during internal, external and FDA Audits.
- Manage in the creation and implementation of appropriate laboratory Corrective Actions and Preventative Actions (CAPAs).
- Manage QC Chemistry 2-year document review.
- Assist in management of the stability management Program.
- Compile & review COAs for Release & Stability Finished Product
- Review Raw Material COAs for release and annual vendor validation.
- Support LIMS management of standard and chemical inventory, sample workflow, and instrument management as a QC Chemistry Manager role for review and approvals.
- Manage vendor and material qualification activities and annual re-validations.
- To provide guidance for higher level decisions required for change management and deviation investigations.
- Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA , FDA/CVM, HS&E, etc.).
- To work closely with all departments and the Quality Department to ensure the operation of a validated environment according to GMP and other regulatory requirements.
Key Performance Indicators
- Ensure analysts perform analysis according to the applicable GMP Health and Safety and internal procedures
- Adhere with completion of analysis to the agreed deadlines
- Proactive approach to laboratory investigations and other laboratory improvements/continuous improvement.
- Coach and mentor laboratory analysts/technicians to ensure performance within the laboratory is continuously maintained to a high standard.
Competencies
| Quality Conscious, customer-oriented | Proactive |
| Coaching and Mentoring | Awareness and compliant with current regulations |
| Results Focussed | Product and Technical Knowledge |
| Motivates Others | Continuous Improvement |
Person Specification
| Essential | Desirable | |
| Behaviour and Values | (D) Dedication- committed to delivering excellence (E) Enjoyment-enthusiastic and results driven (C) Courage- able to take calculated risks (H) Honesty- honest with a high level of integrity (R) Relationships-team player (A) Ambition- willing and able to go the extra mile | |
| Skills and Experience | Precision and focus on quality Excellent interpersonal and communication skills (written and verbal) across a wide range of disciplines, especially the ability to communicate diplomatically and work effectively in a multi- disciplinary team Problem solving Attention to detail Ability to multitask, set priorities, and meet strict deadlines Demonstrate time management skills Using logic and reasoning to identify solutions to problems Ability to lead, motivate, coach, and teach others First class organizational skills Awareness of GMP regulations for products produced, tested and marketed, within the US Familiar with environmental, health & safety, regulatory, and company standards Computer literate with an attention to detail (formatting) and clarity Experience with HPLC & GC and working in a GMP laboratory environment is required Competency in management and tracking of Quality Control Metrics; OOS, Release, Previous experience of project management, time management, and people management Previous experience working with CVM, CDA, and participating in regulatory agency inspections | Preferred 5 years’ experience working in a pharmaceutical GMP environment Experience of working in a fast paced environment |
| Qualifications | Degree in related subject |
Additional Details
Occasional global travel is required with this role.
Med-Pharmex is an equal opportunity employer and prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender (including gender identity and gender expression), medical condition, genetic information, marital status, national origin, mental and physical disability, military and veteran status, or any other characteristic protected by law.
