Office Administrative and Customer Support
1 month ago
Job Description:
Shift 8-5
onsite
NOTE: experience with MasterControl a plus
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 preferred.
- 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.
- Experience with MasterControl a plus
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