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.
We are presently pursuing top talent in the areas of Quality Control to expand our research and development capability. Ideal candidate should have experience in pharmaceutical prescription drug development, either in new or generic drugs, with generic experience being preferred.
Duties and Responsibilities:
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
- Perform antibiotic potency assays, microbial isolation techniques, gram stains, and support microbial identification process.
- Perform testing to bioburden analysis, biological indicators, growth promotion, and water quality monitoring.
- Perform microbial and particulate monitoring of clean rooms throughout the facility.
- Read microbial plates and interpret test results.
- Perform review of test data with apply Good Documentation Practices (GDP).
- Use LIMS or other computerized systems for entering and approving test results.
- Will be required to perform change requests (e.g. ECR, DCR) when required and complete them in a timely manner. Assure SOPs are updated; prepare and update as determined.
- May be required to conduct investigations into Alert/OOS excursions.
- Ensure laboratory area is maintained in a cGMP state at all times while following all EHS and 5S guidelines. Will be expected to do laboratory walk throughs to ensure area is suitable for hand off to oncoming shifts.
- Actively contribute to a team setting within the laboratory and other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
- Operate and proactively maintain laboratory equipment. Ensure that equipment maintenance is properly documented in a timely manner.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations.
- Support deviation investigations, utilizing problem-solving tools as needed.
- Support execution of validations for lab equipment, lab methods, or facility projects.
- May perform other general laboratory duties as assigned.
Position type/Expected Hours of Work
Here at Med-Pharmex we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We’re particularly keen to hear from those who have/are:
- BS in Microbiology, Biochemistry or related discipline is preferred with 1-4 years of experience in the pharmaceutical (or related) industry.
- Effective organizational skills and ability to plan and suggest resolutions to technical problems.
- Computer literate and competent with a working knowledge of word processing and spreadsheets (i.e. Microsoft Office).
- Must be detail-oriented, conscientious, and responsible.
- Effective interpersonal communication. Must have effective verbal and written communication skills.
- Must be able to lift, push, pull 25 lbs and carry up to 50 lbs.
- This is a full-time on-site position. The candidate must be available to work extended hours as needed to meet deadlines, including weekends from time to time.
Med-Pharmex, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.