Stability Document Coordinator-1
Company Name:
Omnicare
Responsible for maintaining stability databases, files, sample preparation, sample shipments, sample inventory, test protocols, and associated documentation. Compiles data for documentation of stability results. Participates in preparation of investigations, summaries, and reports. Reviews data obtained for compliance to specifications and reports abnormalities. May perform MVTR studies and assist in cleaning validation testing. Maintains paper and computer database records to comply with regulatory requirements, good manufacturing practices, and standard operating procedures.
Coordination with vendors for methods, conferences, samples, quotes, and other information/supplies necessary to initiate stability testing and/or evaluate the impact of any changes to stability.
Inventory control and scheduling of stability samples pull, storage, shipment and scheduling with laboratories to meet business demands.
Tracking of data receipt and follow-up as required assuring timely results are received reporting of overdue stability data and associated follow-up.
Data entry, verification, and review of stability or method tech transfer results and identification of abnormalities.
Creation and maintenance of stability studies and files within stability database and stability folders to ensure accurate status of studies, reasons for cancellation or changes, and other documentation.
Performance/documentation of other activities as needed, such as MVTR testing, assisting with cleaning validation, environmental monitoring, and sample preparation.
Compliance with cGMP guidelines, SOPs, and written procedures for all activities completed.
Minimum (Required)
Qualifications: _(must be met in order to perform the job at the required level)_
B.S. Degree or Associates Degree, and
2 years related work experience or similar combination of education and experience.
Proficient in MS Office applications and capable of consistent accurate operations using a technical stability database.
Excellent oral and written communication skills.
Ability to multi-task and achieve deadlines associated with specific job tasks/functions.
Ability to prioritize.
Proofreading skills.
Preferred
Qualifications: _(if above and beyond the minimum required)_
Quality Assurance/Pharmaceutical Experience.
Formal GMP training or equivalent experience in regulated industry.
Associate or Bachelor's Degree in Chemistry.
Physical Demands: May sit, stand, stoop, bend, and walk intermittently during the day. May sit or stand seven (7) to ten (10) hours per day. May be necessary to work extended hours as needed. Finger dexterity to operate office equipment required. May need to lift up to seventy-five (75) pounds on occasion. Visual acuity to see and read fine prints. Specific vision abilities required by this role include close vision, color vision and the ability to adjust focus. Must be able to hear normal voice sounds. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this role.
Work Environment: Work in a climate-controlled, smoke-free internal environment.
Equal Opportunity Employer: Omnicare is fully committed to employing a diverse workforce. We recruit and retain talented individuals without regard to gender, race, age, marital status, disability, and veteran status or any other status protected by federal, state or local law. Omnicare is an Equal Employment Opportunity and Affirmative Action Employer.
Date: 2014-04-28
Country: US
State: KY
City: Glasgow
Postal Code: 42141
Category: Admin/Clerical
Job Type: Regular Full-TimeEstimated Salary: $20 to $28 per hour based on qualifications.
Omnicare
Responsible for maintaining stability databases, files, sample preparation, sample shipments, sample inventory, test protocols, and associated documentation. Compiles data for documentation of stability results. Participates in preparation of investigations, summaries, and reports. Reviews data obtained for compliance to specifications and reports abnormalities. May perform MVTR studies and assist in cleaning validation testing. Maintains paper and computer database records to comply with regulatory requirements, good manufacturing practices, and standard operating procedures.
Coordination with vendors for methods, conferences, samples, quotes, and other information/supplies necessary to initiate stability testing and/or evaluate the impact of any changes to stability.
Inventory control and scheduling of stability samples pull, storage, shipment and scheduling with laboratories to meet business demands.
Tracking of data receipt and follow-up as required assuring timely results are received reporting of overdue stability data and associated follow-up.
Data entry, verification, and review of stability or method tech transfer results and identification of abnormalities.
Creation and maintenance of stability studies and files within stability database and stability folders to ensure accurate status of studies, reasons for cancellation or changes, and other documentation.
Performance/documentation of other activities as needed, such as MVTR testing, assisting with cleaning validation, environmental monitoring, and sample preparation.
Compliance with cGMP guidelines, SOPs, and written procedures for all activities completed.
Minimum (Required)
Qualifications: _(must be met in order to perform the job at the required level)_
B.S. Degree or Associates Degree, and
2 years related work experience or similar combination of education and experience.
Proficient in MS Office applications and capable of consistent accurate operations using a technical stability database.
Excellent oral and written communication skills.
Ability to multi-task and achieve deadlines associated with specific job tasks/functions.
Ability to prioritize.
Proofreading skills.
Preferred
Qualifications: _(if above and beyond the minimum required)_
Quality Assurance/Pharmaceutical Experience.
Formal GMP training or equivalent experience in regulated industry.
Associate or Bachelor's Degree in Chemistry.
Physical Demands: May sit, stand, stoop, bend, and walk intermittently during the day. May sit or stand seven (7) to ten (10) hours per day. May be necessary to work extended hours as needed. Finger dexterity to operate office equipment required. May need to lift up to seventy-five (75) pounds on occasion. Visual acuity to see and read fine prints. Specific vision abilities required by this role include close vision, color vision and the ability to adjust focus. Must be able to hear normal voice sounds. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this role.
Work Environment: Work in a climate-controlled, smoke-free internal environment.
Equal Opportunity Employer: Omnicare is fully committed to employing a diverse workforce. We recruit and retain talented individuals without regard to gender, race, age, marital status, disability, and veteran status or any other status protected by federal, state or local law. Omnicare is an Equal Employment Opportunity and Affirmative Action Employer.
Date: 2014-04-28
Country: US
State: KY
City: Glasgow
Postal Code: 42141
Category: Admin/Clerical
Job Type: Regular Full-TimeEstimated Salary: $20 to $28 per hour based on qualifications.
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