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- Audit and manage QAU oversight on assigned studies following 40 CFR 160 while maintaining complete separation and independence from personnel engaged in the direction and conduct of the study.
- Maintain knowledge of current quality and GLP practices, literature and applicable professional regulations and interpret relevant regulations and apply them to PFG.
- Accountable for supporting regulatory compliance of assigned GLP studies, ensuring procedures are followed and record-keeping requirements are met through critical phase audits and periodic status reports and inspections with written and properly signed records of the inspections.
- Identify training needs of PFG personnel engaged in the conduct of the GLP studies and maintain training records and supporting documentation.
- Assist in the development of corrective and preventive action (CAPA) when appropriate and ensure effective reporting mechanisms are developed and followed.
- Responsible for the review of GLP studies, test protocols, data, and reports conducted at PFG or CROs.
- Responsible for immediate notification of the Study Director and Management of any problems found during or independent from an audit that are likely to impact study integrity.
- Ensure QA procedures and documentation are accurate and relevant.
- File documents in the document storage room and maintain the organization of the document files.
- Assist with initiating and maintaining controlled documents, which includes obtaining approval signatures, scanning, and archiving.
- Monitor raw material and finished product sampling, testing, and disposition assuring adequate, appropriate, and complete documentation and traceability.
- Monitor manufacturing plant and company personnel for compliance to GLP, cGMP, and ISO specifications and protocols.
- Ensure that there are standard operating procedures or batch records in place for all manufacturing processes performed at PFG manufacturing locations.
- Assist in supplier and internal audits as required.
- Support the investigation of commercial complaints, commercial corrective actions, and nonconforming materials.
- Confer with PFG management to identify, plan, and develop methods and procedures to obtain greater efficiency, quality, and compliance within the plant.
- Conduct employee training sessions as needed and as applicable to ensure company compliance to GLP, cGMP, and ISO specifications.
- Maintain awareness of R&D and manufacturing policies, safety concerns, and environmental conditions that can affect product quality.
- Ensure the promotion of awareness of customer requirements throughout the organization.
- Move quickly and efficiently under tight deadlines.
- Comply with all safety policies, practices and procedures, and report all unsafe activities to appropriate supervisor.
- Participate in efforts to achieve departmental and company goals.
- Provide leadership to others through example and sharing of knowledge and skill.
- Perform other duties as assigned.
- A four-year degree in a Chemical or Biological discipline or four years of applicable laboratory or Quality Assurance experience is required for this position.
- Prior experience working in a regulated laboratory setting preferred.
- 401(k) plan with employer match
- Medical, dental, & vision coverage
- Life insurance coverage
- Long term disability
- Flexible spending account for dependent care and/or medical expenses
- Employee Assistance Program
- Vacation accrual starting on first paycheck
- 13 fully paid holidays
Quality Assurance Assistant - Davis, United States - PRO FARM GROUP INC
Description
Job DetailsJob Location
MAIN OFFICE - DAVIS, CA
Position Type
Full Time
Education Level
4 Year Degree
Salary Range
$66, $75,000.00
Travel Percentage
0-10%
Job Shift
Any
Job Category
QA - Quality Control
Description
SUMMARY:
ProFarm Group (PFG) is a subsidiary of Bioceres Crop Solutions, a global provider of biologically-derived fertilizers, inoculants, crop traits, adjuvants, biostimulants and pesticides, serving the ever-expanding agricultural markets. PFG focuses on discovering, developing, and marketing nature-derived biostimulants, as well as pest management products from microbes and plant extracts for the effective control of invertebrate pests, weeds, and plant diseases.
We are currently looking for an Assistant to join our Quality Assurance group. This position will help support facility compliance to GLP and manufacturing standards, maintain test records and SOPs generated or utilized by the company, and is responsible for reviewing studies, test data, and assembling data packages for product release. The assistant should possess knowledge of biology and be familiar with general lab equipment and practices.
RESPONSIBILITIES AND DUTIES:
Essential Functions
Qualifications
Education and Experience
Ability to read, analyze, and interpret common scientific and technical journals, technical procedures, and governmental regulations. Possess the ability to write reports, business correspondence, and procedures. Effectively present information and respond to questions from managers and peers
Mathematical Skills
Able to calculate figures and amounts such as area, length, and volume. Able to calculate and apply concepts such as fractions, percentages, ratios, and statistical functions to practical situations.
Reasoning Ability
Ability to define problems, collect data, establish facts, and draw valid conclusions. Able to interpret a variety of technical instructions in mathematical or diagram form and ability to deal with nonverbal symbolism such as graphs, formulas and scientific equations.
Computer Operations
Possess intermediate personal computer skills including electronic mail, routine database activity, word processing, spreadsheets, and graphics.
Planning/Organization
Capable of handling and planning multiple tasks and projects simultaneously under stringent deadlines.
The Quality Assurance Assistant must have manual dexterity sufficient to handle items and perceive attributes of objects, and be able to perform light physical, non-strenuous daily activities of a productive/technical nature. Must be able to function in working conditions that are adequately lighted, moderately heated or air-conditioned, and in an indoor office, laboratory, and production setting. In the course of daily activities, assistants may be occasionally required to lift up to 30 pounds, are frequently exposed to air contamination such as disagreeable odors and may be exposed to toxic or caustic substances.
BENEFITS:
The above is a list of essential duties and responsibilities for this position. This list is not all-inclusive and other duties may be assigned. This job description may be modified as needed.
PFG is an equal-opportunity employer. A pre-employment background check will be required.