MINARIS MEDICAL AMERICA
Operation Associate I
The Operations Associate I position is located in Mountain. View, CA. The incumbent will receive general instructions for routine work. This position will use current Good Manufacturing Practices to perform a variety of production line tasks to include part assembly, labeling, packaging, inspections and lot accountability. Work is performed in a clean manufacturing environment. This position will also maintain batch records to comply with regulatory requirements, current Good Manufacturing Practices, and Standard Operating Procedures. This position will assist with product shipments and the staging of production order materials. This position may be exposed to blood serum, hazardous chemicals and loud noises.
Essential Duties and Responsibilities
- Perform routine visual inspection on in-process materials according to documented specifications
- Communicate effectively with co-workers and supervisor
- Communicate with supervisor and department lead regarding any excessive damaged or substandard assembly work and defective parts, tools, equipment, material or other conditions which hinder assembly process
- Respond in a timely manner to manufacturing needs. Maintain, operate, and troubleshoot production and test equipment. Clean and maintain work area and equipment. Perform line clearances and inspect components
- Package and assemble diagnostic test kits; operate production line machinery and computers according to cGMP, batch records, Manufacturing Operating Procedures and safety policies
- Follow and provide feedback on Standard and Manufacturing Operating Procedures, Work Instructions, and Manufacturing Batch Records.
- Organize and maintain maintenance and cleaning logs for manufacturing equipment
- Assist with International and Domestic shipments
- Assist with routine inventory cycle counting – weekly, quarterly and end of year physical count
- Assist with pulling/staging of Manufacturing materials for production orders
Position Requirements (Knowledge, skills and abilities required to perform satisfactorily in the position)
- Working knowledge of cGMP requirements (preferred)
- Ability to follow instructions and communicate clearly and concisely in English, both orally and in writing
- Basic knowledge and experience with PC and Microsoft applications (Excel, Word and Outlook are required)
- Basic reading, writing in English, arithmetic, and critical thinking skills
- Detail oriented, ability to reconcile and document daily tasks.
- Manual dexterity required for quick and accurate assembly of small parts and operation of equipment
Education and Experience
- High School Diploma (Prefer AS or equivalent college course work in Chemistry or Life Sciences)
- Minimum one (1) year experience in a cGMP Manufacturing environment of the biotech or pharmaceutical industry (preferred).
- Manufacturing/warehouse environment
- Dry or cold (2 to 8 degrees) temperatures (occasional)
- Loud noises (occasional)
- Potential exposure to human blood serum, ozone, and hazardous chemicals
- Machinery operation requires the use of safety equipment to include, but not limited to, lab coat, eye safety glasses, slip-resistant safety shoes, and hearing protection
- Frequently lift up to 25 pounds (for up to 2 hours at a time and up to 8-10 hours total in a day)
- Frequent use of hands (for up to 2 hours at a time and up to 8-10 hours total in a day)
- Long periods of standing (continuously for up to 2 hours at a time and up to 8-10 hours total in a day)
- Ability to visually discern printed characters as small as 1/16”; Close and distant
- Ability to work in a cold room environment (2-8 degrees) for a period of up to 2 hours at a time
Position type and expected hours of work
On-call, as needed and when available.
$18.15 – $23.00 per hour
Affirmative action plan/equal employer opportunity (AAP/EEO) statement
Minaris Medical America, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, marital status, pregnancy, sex, gender expression or identity, sexual orientation, citizenship, genetics or any other legally protected class. In addition to federal law requirements, Minaris Medical America, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
The above statements are intended to describe the general nature and level of the work being performed by people assigned to this work. This is not an exhaustive list of all duties and responsibilities. Minaris management reserves the right to amend and change responsibilities to meet business and organizational needs as necessary, at any time with or without notice.