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Document Control
1 month ago
Duration: 12 Months
Pay range: $25-$25.00/hr.
Onsite Job
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.
- 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.
- 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
At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits:
- Four options of medical Insurance
- Dental and Vision Insurance
- 401k Contributions
- Critical Illness Insurance
- Voluntary Permanent Life Insurance
- Accident Insurance
- Other Employee Perks
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.