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Website Medpharmex

U.S. Work authority required.

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.

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.

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.

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.

Quality Conscious, customer-oriented Proactive
Coaching and Mentoring Awareness and compliant with current regulations
Results Focussed Product and Technical Knowledge
Motivates Others Continuous Improvement

Dedication- committed to delivering excellence
Enjoyment-enthusiastic and results driven
Courage- able to take calculated risks
Honesty- honest with a high level of integrity
Relationships-team player
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

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.

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