Operations Specialist- Quality & Manufacturing

For further inquiries regarding the following opportunity please contact our Talent Specialist.

Marshelin at

Title: Operations Specialist- Quality & Manufacturing

Duration: 6 Months (Possibility of extension based on demand.)

Location: On-site at Woodland CA

Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.

Travel Requirements - No Travel

Description:



Scope of Position:
Ensure that documented practices meet the true interpretation of the Serum CoE Quality Management System. Complete day-to-day manufacturing tasks which include manufacturing products in a clean room environment.



Day to Day Responsibilities:
Support Serum CoE Quality Systems by creating maintaining and executing Quality Systems in
compliance with ISO 13485 and FDA 21 CFR 820.
Compile and organize all quality related documentation and ensure all documents are filed in a
manner that allows for easy access for regulatory and customer audits.
Issuing of labels and batch record documentation for all products.
May assist with writing of new and revising existing MMRs and QOPs to ensure procedures are
accurate up to date and are in compliance with current Good Manufacturing Practices and ISO
13485.
Ensures all scheduled products are manufactured according to company procedures and cGMPs to achieve customer satisfaction and conformance to company schedule/deadlines
Understands the concepts of aseptic technique to operate inside Class 1000 and Class 100 cleanroom areas as well as other controlled areas
Performs quality inspections on incoming and outgoing materials and products
Sorts and places materials or items on racks shelves or bins according to predetermined inventory procedures
needed
Completes batch records in an accurate and timely manner following each days production
Formulates finishes manufactures and fills all products produced at the plant with minimal guidance
Monitors equipment and completes basic equipment maintenance and cleaning activities
Utilizes and records readings from laboratory and manufacturing equipment
Closely follows work instructions provided in writing or verbally by supervisor/plant leadership
Moves stacks of crates from freezer to packaging area with hand truck/dolly to complete work
Inspects and packages product by checking for damaged bottles labels and/or heat shrinks that do not meet established standards
Labels bags boxes and palletizes finished product in accordance with plant deadlines
Provide input to new and revising existing SOPs to ensure procedures are accurate up to date and in compliance with current Good Manufacturing Practices
Responsible for reporting quality and safety issues to immediate supervisor
Ensures personal training documentation is up to date and aid in the training of others as needed
Maintain organization and cleanliness of production areas
Special assignments and other responsibilities as required



Hours of work/work schedule/flextime:
40 hours/week Monday-Friday



Education:
Minimum required: Associate degree and relevant experience
Preferred: 4-year Biology Degree or Chemistry degree



Required Years and Area of Experience:
1-3 years of experience in Production Manufacturing Engineering and/or Quality



Required Skills:
Ability to develop update and train on SOPs.
Working knowledge of ISO standards and cGMP.
Knowledge of computer programs such as Word Excel PowerPoint etc.
Good organizational skills; strong time management skills.
Strong interpersonal and communication skills.
High attention to detail.



Preferred Skills:
Experience in a medical pharmaceutical or biotechnology environment preferred.
SAP and/or PeopleSoft experience preferred.



Working Conditions:
Part time office environment part time manufacturing environment. Frequently lifts and/or moves up to 25 pounds and up to 60 pounds occasionally; rarely lifts over 60 lbs. Use of noxious or hazardous chemicals with appropriate PPE. Protective clothing or equipment may occasionally be required including gloves freezer jacket or jumpsuit protective eyewear footwear. May perform work in a clean room environment.


** Includes use of a respirator in this role.

Interview Process:

One Round Onsite Interview with Hiring Panel

About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.