Senior Manufacturing Associate

Advantage Resourcing
Published
January 1, 2021
Location
Pacheco, CA
Category
Job Type

Description

Advantage Resourcing is seeking a Senior Manufacturing Associate for our client in Pacheco, CA. 
Summary/Objective
A senior level position responsible for manufacturing activities with little or no supervision.
Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
1. Adhering to GMP:
a. Ensure all containers and measuring devices are cleaned per protocol
b. Monitor equipment and instrumentation for compliance to corporate procedures
c. Ensure all raw materials are properly labeled and in their appropriate locations
d. Document control
2. Assembly of Finished Products:
a. Filling and labeling of stock solutions
b. Printing labels and data sheets for appropriate task
c. Generating records associated with Manufacturing process
3. Production Support:
a. Updating SOPs, batch records
b. Production of Antibodies and Bioreagents, as necessary
c. Maintaining and analyzing lot histories/trends
d. Documenting all activities associated with production
e. Performing process development and validation outputs activities
f. Ensuring all necessary equipment is validated and calibrated
4. Automated Equipment:
a. Operation and monitoring Autobagger
b. Operation and monitoring Automated Filling Line
5. Mechanical aptitude and competence to perform routine adjustments and preventative maintenance to the automated manufacturing equipment.
6. Monitoring and stocking of laboratory supplies.
7. Other duties as assigned by Management.
Competencies
Familiarly with cGMP, FDA, and ISO Regulations.
Proven experience working in a cross-functional team.
Ability to interface with business system as necessary i.e. SAP, GP, etc.
Work under high-pressure deadlines.
Strong organizational skills with the ability to structure the work schedule.
Independent judgement with problem solving.
Communication.
Critical Evaluation.
Troubleshooting.
Basic Computer skills with Word, Excel, and Outlook.
Accuracy and attention to details.
Ensures that all SOP’s are followed and recommend Quality Improvement Measures.
Supervisory Responsibility
This position has no supervisory responsibility.
Work Environment
This job operates in a professional laboratory environment. This role routinely uses standard laboratory equipment. For related administrative responsibilities, this role routinely uses standard office equipment such as a desktop computer. The worker is not substantially exposed to adverse environmental conditions (such as in typical office or administrative work.)
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is required to stoop: Bending body downward and forward by bending spine at the waist. Kneel: Bending legs at knee to come to a rest on knee or knees. Crouch: Bending the body downward and forward by bending leg and spine. Reach: Extending hand(s) and arm(s) in any direction. Stand: Particularly for sustained periods of time. Walk: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another. Lift: Raising objects from a lower to a higher position or moving objects horizontally from position-to-position. Finger: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling. Grasp: Applying pressure to an object with the fingers and palm. Feel: Perceiving attributes of objects, such as size, shape, temperature, or texture by touching with skin, particularly that of fingertips. Talk: Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly. Hear: Perceiving the nature of sounds at normal speaking levels with or without correction. Ability to receive detailed information through oral communication, and to make the discriminations in sound. Repetitive motion: Substantial movements (motions) of the wrists, hands, and/or fingers.
Light work: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes. The worker is required to have visual acuity to perform an activity such as: operates machines. The worker is required to have visual acuity to determine the accuracy, neatness, and thoroughness of the work assigned.
Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus.
Required Education and Experience
High School Diploma or GED with two to five (2-5) years’ experience in a cGMP-Controlled Manufacturing Environment.
Bachelor of Science Degree in a Chemistry field is preferred.

About Advantage Resourcing

Advantage Resourcing is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Resourcing is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.

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