Overview
TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.
Position: Document Control Assistant
Location: West Hills, CA 91304
Duration: 12 Months
Job Type: Contract
Work Type: Onsite
Shift Timings: 08:00 AM to 05:00 PM
Position Summary
- Responsible for efficiently processing Document Change Requests (DCRs), including routine data entry, coordinating document review/approval/release per department SOPs.
- Provide administrative support in accordance with departmental procedures.
- This position will ensure all records are maintained in a manner compliant with company policy.
Responsibilities
- Ensure safe and efficient handling and processing of controlled documents and document control related activities in accordance with documented standard operating procedures.
- Responsible for the routine maintenance of active and archived controlled documents and records in accordance with department SOPs.
- Responsible for checking the “Document Change Request” mailbox on a daily basis for DCR requests.
- Responsible for proficient initiation/coordination of Collaboration Tasks and Releasing of assigned document(s) within Master Control in a timely manner
- Ensure new/revised software analysis files are disposition according to defined document specifications and plans.
- Coordinate the translation of all required documents.
- Manage and maintain off-site storage, document retention and retrieval of documents per department SOP.
- Assist with printing document copies for packaging/shipping as needed.
- Assist with reviews and edits to SOPs as needed.
- Assist with audits in retrieving documents and supplying them to the audit team in a timely/urgent manner
- Support QA department with all other misc. administrative tasks as needed.
- Process Master Control DCR(s) as assigned by Document Control Supervisor.
- Maintain accurate account of electronic and hard copy records for all applicable QS documentation.
- Provide assistance with editing, formatting and final drafting of SOPs as requested and approved by supervisor.
- Records retention, storage and retrieval.
- This position will have contact with all OLI staff.
- This position will keep confidential all laboratory data and business information.
- This position must maintain a cooperative and professional relationship with all OLI staff.
Minimum Requirements/Qualifications
- A high school diploma minimum. Some college is desirable. 2-5 years related work experience.
- Prior work with documentation in a GMP manufacturing environment.
- Experience with MasterControl is required
- Proficient in Microsoft office, including MS Word, Excel.
- Knowledge of GMP document control regulations a plus
- Follow instructions, organizational, written and verbal communication skills important.
- Attention to detail important.
- Exercise independent discretion and judgment in execution of his/her duties.
- Plan and organize oneself in an efficient and consistent manner.
- Learn new applications and procedures.
- This position will operate a computer terminal on a daily basis.
- Occasional lifting of equipment of up to 35 pounds.
- Department Supervisor/Manager shall identify the required departmental training in accordance with the documented position training requirements.
TekWissen® Group is an equal opportunity employer supporting workforce diversity.
TekWissen is an emerging global human capital, recruitment and IT services organization. Operating since 2009, we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We’re founded on a culture that is passionate about delivering tailored solutions, that create lasting partnerships.
Our global footprint covers six countries: United States, Canada, Australia, India, United Kingdom and the Philippines. This allows us to work in close partnership with organizations and manage everything from global talent needs with demanding resourcing strategies, to single sites with lower recruitment volumes.
TekWissen® is an equal opportunity employer supporting workplace diversity.