ASQ 0502 JobSeekers

Essential Job Functions:
Responsible for ensuring that GMP operations are being conducted according to internal and external quality requirements by administering an integrated quality system function. Responsible for leading quality system continual improvement initiatives as well as interfacing with other functional areas including manufacturing, facilities, QC, and other Quality departments to oversee activities as they relate to product quality and quality systems. Interprets regulatory requirements and implements quality procedures, administers quality systems, assists in facilitating regulatory compliance inspections and conducts supplier audits. Reviews documents and records such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc., to ensure fulfillment of quality and compliance related requirements.

Position Requirements
1. Manages workflow to assure the timely supply of commercial products and clinical materials.
2. Provides technical guidance and oversight as it applies to the required quality standards
3. Employs metrics to identify and communicate potential schedule adherence issues and works towards their resolution.
4. Assists with the compilation and publication of quality metrics (deviations, CAPA, root cause, etc) for Manufacturing, QC and QA activities. Uses the data to help drive quality improvement in documentation practices and production related activities.
5. Ensures investigations for minor and major deviations are performed according to quality requirements and that the conclusions identify root causes and recommends/implements corrective actions to prevent recurrence.
6. Collates and analyzes data for the annual product reports.
7. Performs audits of manufacturing, analytical testing, labeling areas to ensure compliance with SOPs and company policies.
8. Provides leadership and guidance to peers in the QA department and to other functional areas.

Position Summary:
Responsible for ensuring that GMP Operations are being conducted according to internal and external quality requirements by administering and improving an integrated quality system function.
Knowledge: Able to translate strategic vision into tactical solution. Knowledge of operational excellence as well as risk management principles in order to support continual improvement initiatives and assessments. Excellent knowledge of EU and US GMPs. Technically superior with biopharmaceutical manufacturing and testing operations, including cell culture and purification.
Problem Solving: Able to independently identify and resolve complex problems using functional and technical knowledge.
Discretion / Latitude: Works under general direction. Independently determines and develops approaches to solutions. Reviews work to assure consistency with site and corporate objectives. Work is reviewed upon completion for adequacy, in meeting objectives.
Impact: Leads the completion of specific programs, teams and projects. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
Liaison: Frequent inter-organizational and outside customer contacts. Must be able to communicate verbally and in writing and represent the function effectively.
Typical Education: Bachelors in Life Sciences or Engineering required, Masters of Science in the same disciplines is preferred
Typical Experience: 7-10 years experience in Biotech/Pharma industry
Technical Knowledge: GMPs, Database knowledge, deviation investigations, root cause corrective actions, trend analysis
Computer Skills: Outlook, Explorer, Excel, Powerpoint, Word, MS Project

Please refer to job code 01790 when responding to this ad.

Category:    Information Technology         > Systems/Network Administrator
Location:    Gaithersburg, MD    County:    Montgomery County    ZIP Code:    20877
Pay Rate:    Open    Job Terms:    full time

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