Regulatory Compliance Specialist - Quality Systems

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POST DATE 9/9/2016
END DATE 10/8/2016

Alcami Germantown, WI

Germantown, WI
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Full Time
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Alcami is a leading provider of services that encompass the entire process of pharmaceutical drug development from discovery through commercialization. We specialize in analytical chemistry, formulation development, clinical packaging, oral drug delivery and contract manufacturing. The company has experienced significant growth and we have continued to attract the most highly skilled professionals in the industry.

With nearly 1,000 employees operating out of seven sites in the US and Europe, our combined capabilities include API development and manufacturing are worldly recognized. Come join our team!


Located in Germantown, Wisconsin, Alcami is part of the growing southeast Wisconsin biotech/pharma cluster. The area boasts global market leaders in contract pharmaceutical services, and a rapidly growing number of academic incubators. A short drive from Chicago, Madison and Milwaukee, Germantown offers residents a small town quality of life with convenient access to major Midwest cities. Residents enjoy an excellent school district and many local recreation attractions, in addition to national sports teams (Green Bay Packers and Milwaukee Brewers and Bucks), and a vibrant waterfront park community that includes world class art museums and children's museums.

Position Summary:

The Regulatory Compliance Specialist effectively performs activities as directed to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting audits and inspections, hosting audits and inspections, and maintaining quality databases. Assists with the development of SOPs or other quality documents as needed.

Key Job Responsibilities:

Performs quality review and approval of documents, data, protocols, and/or reports.

* Performs internal and external quality audits and/or inspections.

* Hosts client audits and inspections

* Maintains quality databases.

* Assists with the implementation and supports quality systems, including but not limited to vendor management, training, internal audit program, and overall regulatory inspectional readiness initiatives.

* Assists with quality improvement initiatives as needed.

* Assists with development of SOPs or other quality documents as needed.

* Effectively performs duties, on schedule, with accuracy and competency.

* Maintains accurate files and records; accurately reports time in applicable time-keeping system.

* Serves as an effective member of the Regulatory Compliance team.

* Performs other duties as assigned.

* Complies with company polices and SOPs.

* Works the hours necessary to meet scheduling commitments, is punctual with minimal absenteeism.

* Travel: Some domestic and international travel may be required.

Essential Job Requirements:


* Bachelors degree in Chemistry, Biology, or related field with GMP related experience, or equivalent educational and work experience.

We invite all qualified applicants to apply. We offer competitive salary, a comprehensive benefits package and opportunity for advancement.

Alcami is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.