Operations Specialist II

Operations Specialist II

Medical Devices Company

Position : Operations Specialist II

Location : San Diego, CA

Duration : 9 Months 

Total Hours/week : 40.00

1st shift

Client: Medical Device Company

Job Category: Healthcare

Level Of Experience: Mid-Level

Employment Type: Contract on W2 (Need US Citizens, GC Holders)

Work hours: 8:00am – 4:30pm

3 Must haves on the resume: 

Bachelor degree in Chemistry/Biology, Prior experience in a chemistry laboratory (2+ years), Prior experience with manual and automated pipetting

Job Description:

• The Operations Specialist II is a multi-functional role, responsible for inventory control of materials and finished goods, formulation, packaging, and order fulfillment. 
• The Operation Specialist II also supports Quality Control of finished goods by performing dye labeling reactions and sample preparation. 
• In addition, this position assumes additional responsibilities such as managing the scheduling and proper documentation of preventative maintenance, calibration and repairs of new and existing equipment/instruments.

Roles & Responsibilities

Duties & Responsibilities:

• Ensures security and accuracy of inventory of materials and finished goods through transaction documentation and by conducting physical cycle counts and reconciliation of any discrepancies.
• Manage physical inventory within a Glovebox for raw materials, intermediate products, finished goods, analytical samples, and QA Retains.
• Perform small scale chemical reactions (dye labeling) for Quality Control testing.
• Fulfill internal requests for samples from inventory and perform sample preparation for quality testing.
• Perform Aliquoting/Vialing of air and water sensitive finished goods using manual and automated processes and equipment.
• Perform lyophilization of finished good products.
• Perform Weight Checks and Packaging of air and water sensitive finished goods within a Glovebox.
• Prepare packaged products for QA inspection and shipments, including all required documentation.
• Coordinate with QC department to ensure timely testing and release of production materials.
• Accurately complete required documentation (batch records, data entry, etc.) on time.
• Manage the scheduling of service, preventative maintenance, and calibrations by coordinating work with contractors and laboratory associates and maintaining all associated equipment records including new equipment and retirement of equipment.
• Support document control and data archiving activities as assigned.
• Participate in non-conforming material, equipment out of tolerance, and customer complaint investigations.
• Promotes a safe work environment. Provide recommendations on maintaining the safety of the work environment. 
• Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. 
• Notifies supervisor of all observed hazardous conditions or unsafe work practices. Participates in safety audits of safety equipment and laboratory processes.
• Other responsibilities or projects as assigned by reporting manager.

Experience Required

• 2+ years relevant experience.

Skills & Certifications

Assets:

• Ability to follow standard operating procedures is essential.
• Experience with manual (pipette) and automated filling/dispensing is required.
• Prior experience in a chemistry lab is required.
• Experience working in a glovebox is preferred.
• Experience with Good Documentation Practices and ISO certified or regulated environment is preferred.
• Proficiency in MS Office Skills (Word, Excel, and PowerPoint) is required.
• Experience with SAP, BMRAM, and DocuNECT is preferred.
• Experience with root cause analysis/investigation preferred.
• Must possess strong organizational skills, attention to detail, and the ability to adapt to changing priorities in a fast-paced environment.
• Be a self-starter, quick learner with the ability to work independently and efficiently.
• Strong interpersonal communication skills, effective written and oral communications skills.

Eligibilities & qualifications

• Typically requires a minimum of a Bachelor’s Degree in chemistry or biology with 2+ years relevant experience.