Fda Regulatory Entry Level Jobs (NOW HIRING)

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Position Summary:

In general, the Manufacturing Lead Technician is responsible for overseeing the coordination and operations of the production schedule, shift, and personnel.

Essential Job Duties:

• Responsible for equipment setup and operation in a biologics processing environment for plasma derived pharmaceuticals.
• Strict adherence to procedures and practices according to FDA regulations.
• Strong emphasis on documentation according to FDA regulations.
• Adhere to departmental corporate safety policies.
• Responsible for facility and equipment cleaning.
• All work is performed in a clean room (sanitized) manufacturing environment.
• Responsible for basic process analysis such as pH, refractive index, turbidity, and conductivity measurements.
• Operates manufacturing equipment such as ultrafiltration (UF) units, chromatography columns, Clean In Place (CIP) systems, Steam In Place (SIP) systems and centrifuges.
• Utilizes touch screen Operator Interface Terminals (OIT). 
• Trains entry level personnel.
• Performs more complex and advanced job tasks.
• Assist management in coordinating and scheduling the department's day to day operations.
• Serves in a leadership role in the absence of direct supervision.
• Other duties may be assigned.

REQUIRED EXPERIENCE/SKILLS & EDUCATIONAL QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

• High school diploma or GED required.  Associate's degree, applicable certification, and/or military veterans preferred.
• Minimum of 3 years of related experience in a pharmaceutical, GMP, or FDA regulated environment is required.
• Demonstrated leadership skills with the ability to motivate, guide, train, coach and develop department personnel.
• Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
• Ability to work independently with minimum supervision.
• Must be proactive, results oriented, and have strong attention to detail.
• Self-starter with strong work ethic and the ability to exercise good judgment.
• Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
• Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
• Must be able to read, write, and speak English.
• Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
• Must be flexible with working hours / shifts in order to accommodate the 24-hour, 7 day plant operation.

Occupational Demands: 

Work is performed in a manufacturing environment with rotating shifts. Exposure to biological fluids with potential exposure to infectious organisms.  Exposure to chemicals, electrical manufacturing equipment, hand tools and moving machinery.  Operate power equipment. Exposure to high levels of noise and to dust/gas/fumes/steam.  Exposure to extreme cold below 32* and on occasion, exposure to extreme heat above 100*.  Exposure to vibration or oscillating movements of the extremities or the whole body.  Occasional entry into confined spaces, requiring kneeling, crawling, climbing and squatting.  Works at heights on scaffolding and/or on ladders.  Walks on uneven ground. Personal protective equipment required such as: protective eyewear, face shields, chemical suits, safety shoes and/or rubber footwear, gloves, hearing protection and a respirator. Heavy lifting and carrying of 50lbs. for up to 6-8 hours per day, with a maximum lift of 75lbs. Work is performed standing, walking, bending and twisting waist for 4-6 hours per day. Frequent foot movements. Occasionally reaches above and below shoulder height. Occasionally bends and twists neck.  Frequent hand movements with simple grasping of one hand with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.  Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Hearing acuity essential.  Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences.  Performs a wide range of complex tasks. Adheres to a work schedule to meet production standards.                                    

*This job description is accurate at the date of publication.  It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position.  Other duties may be assigned and qualifications required may change over time.

The estimated pay scale for Manufacturing Lead Technician role based in California, is $34.00 to $35.00 per hour. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.  We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

California Personnel Privacy Policy and Notice at Collection

Location: NORTH AMERICA : USA : CA-Los Angeles:USVALLEY - Valley Bl Mfg Plant - LA, CA

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