PURPOSE OF THE POSITION
Ensure that all aspects of product release meet analytical, production, packaging, and labeling specifications in accordance with customer requirements and established quality systems. Support the maintenance, development and improvement of ISO quality systems through auditing (internal, supplier, and customer), training, process validation, cleaning validation, equipment qualification, change control, complaint handling, and documentation control.
ESSENTIAL JOB FUNCTIONS
' Ensure acceptable product and process consistency
a. Review batch documentation to determine whether process and laboratory results meet the predetermined acceptance criteria for release. Report all process deviations and/or laboratory OOS results. Investigate QA-pertinent process anomalies.
b. Initiate and coordinate the Change Control Program for all product quality-related changes to documents, equipment, specifications and methods.
c. Participate in the internal and supplier audit programs by conducting, reporting, and tracking audit results.
d. Write and/or review Operating Procedures, Validation Protocols/Reports, Manufacturing Batch Records, and other QA-controlled documents for all departments under QMS. Coordinate the security and availability of the approved documents for all departments.
e. Coordinate and/or execute equipment qualification activities pertaining to appropriate process equipment and critical systems.
' Interact with customers (internal & external) and implement quality systems.
a. Review customer requests for product agreements pertaining to product specifications, testing protocols, label and documentation requirements.
b. Maintain the records for internal audit observations and issue corrective action reports to the affected production/lab areas. Follow-up with areas to ensure completion of the corrective action tasks within the specified timelines.
c. Issue audit reports following supplier audits and track progress of supplier corrective actions.
d. Respond to quality-related customer questions.
e. Monitor the Supplier Assessment Questionnaire program for rating all supplier programs.
f. Coordinate the timely turnaround of all production documentation being issued or revised through the Quality group.
' Support the Sigma Quality System.
a. Present various ISO quality systems training topics to production, lab, and quality personnel.
b. Coordinate the resolution and completion of customer complaints pertaining to quality and process related issues.
c. Assist with recalls and field corrections as needed.
d. Interact with the production and lab personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
Education and Experience:
' Necessary: BS/BA in Chemistry, Biochemistry, Biology, Engineering, or related Scientific Disciplines.
' Desired: MS, in Chemistry or Biochemistry
' Desired: Certified by an ISO Approved Agency.
' Over 3 years, up to 5 years experience: Experience in ISO-13485 manufacturing, validation, quality assurance, or other functional areas specific for the available position.
Essential and Critical Skills:
' Understanding of the Quality Control test methodology and the associated analytical results including mass spectrometry, high-performance liquid chromatography, and UV/Visible spectrophotometry. Familiar with the accuracy and precision of various common analytical methods.
' Thorough understanding of ISO Quality Systems including ISO-9001:2008 and ISO-13485:2003.
' Good computer skills, including proficiency with MS Word, MS Excel, and MS Access.
' Working understanding of applied statistical calculations including regression analysis.
' General understanding of the principles of process, cleaning, and equipment validation.
' Advanced verbal & written skills for technical protocols and reports, as well as customer response letters.
' Excellent problem solving skills for out-of-specification and process deviation investigations.
' Good time management skills.
' Excellent interpersonal skills for interacting with many internal departments and management levels, along with customers, suppliers, and regulatory authorities.
' Ability to organize and prioritize tasks effectively.
' Capacity for independent work.
Job Contacts and Environment:
Internal Contacts: Daily contact with all area departments to obtain information and solve problems.
External Contacts: Customers for agreements, complaints, audits. Suppliers for information and audits.
Environnent: 70-90% Office Environnent, 10-30% Production, QC, Packaging. Possible travel required for Supplier Auditing.
About Sigma-Aldrich: Sigma-Aldrich is a leading Life Science and High Technology company whose biochemical, organic chemical products, kits and services are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical, diagnostics and high technology manufacturing. Sigma-Aldrich customers include more than 1.3 million scientists and technologists in life science companies, university and government institutions, hospitals and industry. The Company operates in 35 countries and has nearly 9,000 employees whose objective is to provide excellent service worldwide. Sigma-Aldrich is committed to accelerating customer success through innovation and leadership in Life Science and High Technology. For more information about Sigma-Aldrich, please visit its website at www.sigma-aldrich.com.
Sigma-Aldrich offers a highly motivational and rewarding working environment with attractive salary, benefits, retirement, relocation and incentive packages including tuition reimbursement. Sigma-Aldrich fosters the growth of employees in a culture of respect and dignity with ample opportunity for career advancement.
Sigma-Aldrich is an Equal Opportunity Employer
Sigma-Aldrich Corporation - 17 months ago
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