Quality Control Documentation Operations Specialist and Manufacturing

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

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https : / / divihn.com / find-a-job /

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

Marshelin at

(224) 507-1280

Title : Quality Control Documentation Operations Specialist and 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.

Tra vel Requirements - No Travel

The position is involves both production and quality control Documentation tasks.

Approximately 12 hours per week will be dedicated to QC documentation and the rest of the time will be in production.

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 cGMP's to achieve customer satisfaction and conformance to company schedule / deadlines

Understands the concepts of aseptic technique to operate inside Class 1,000 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, SOP's 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

Quality tasks involve generating batch records using software like PeopleSoft and issuing labels

Special assignments and other responsibilities as required

Production tasks include filtering and bottling serum in a clean room environment.

Hours of work / work schedule / flextime :

40 hours / week, Monday-Friday

Documentation Skills : Comfort with controlled documentation and good documentation practices (GDP) is critical.

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

1 3 years in production or clean room environments.

Familiarity with PPE, gowning, aseptic techniques, and FDA-regulated facilities

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.

Strong documentation skills, clean room experience and willingness to perform both manufacturing and paperwork tasks.

Preferred Skills :

Experience in a medical, pharmaceutical or biotechnology environment preferred.

SAP and / or PeopleSoft experience preferred.

Candidates from lab environments are acceptable if they are willing to learn production work.

Experience in CGMP environments, ISO standards, and industries like medical, pharmaceutical, or biotechnology

Strong interpersonal and communication skills

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.