Quality Specialist - United States
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What differentiates us at Alcami? Our people.
Help shape the future of medicine and join us – we are a pharmaceutical contract development manufacturing organization (CDMO).
Alcami Corporation is the first company to offer a solution that is tailored to small and mid-size pharmaceutical and biotechnology companies. We offer a range of services from four distinct pillars: Development Services, Analytical Testing, Drug Product, and APIs. Beyond that, we can integrate our services so customers experience a simplified engagement with a single project management relationship, full visibility from development into manufacturing, and shorter turnaround times. With six locations in the U.S. and a global location in The Netherlands, the Alcami family is growing rapidly. Picture yourself at Alcami and apply today.
The Quality Specialist effectively performs activities using a teamwork-based approach to ensure quality and compliance with acceptable regulatory requirements. These activities may include reviewing documents and data, conducting audits and inspections, and maintaining quality databases. Assists with the development of SOPs or other quality documents as needed.
- Performs quality review and approval of documents, data, protocols and/or reports.
- Performs internal quality audits and/or inspections.
- Provides quality evaluation and release of starting materials, intermediate bulk products, equipment and facilities.
- Maintains quality databases and may perform analysis and trending in support of site metrics.
- Provides consultation on quality and compliance topics in areas of expertise and assists with quality improvement initiatives as needed.
- Provides training in quality and compliance topics in areas of expertise.
- Assists with development of SOPs or other quality documents as needed.
- Effectively performs duties, on schedule, with accuracy and competency with limited supervision.
- Maintains accurate files and records; accurately reports time in applicable time-keeping system.
- Serves as an effective member of the Quality team.
- Supports client / regulatory audits as required.
- Provides Document Control support functions to site personnel.
BA/BS degree in Chemistry, Biology or related field with 3+ years of quality experience related to the manufacturing of sterile or solid dosage form products or MS degree in a related scientific field with 2+ years quality experience related to the manufacturing of solid dosage form products. Experience with Controlled Substance reporting or handling as well as experience with final product release, major equipment validation protocol review, process validation protocol review and APRs is preferred. Experience leading client audits as the facility host is a plus. Must have strong teamwork and organizational skills; excellent verbal and written communication skills; ability to multitask and exercise good judgment; be detail oriented with good follow-up skills; and proficiency in computer usage with standard business software.
What we offer you:
- In Wilmington, an onsite Learning Center for working parents
- Profit sharing bonus plan
- Medical, dental and vision coverage from day one
- A menu of voluntary benefits including short & long term disability, life, accident, critical illness and hospital indemnity insurances
- Paid/flexible sick-leave, vacations, and holidays so you can take the time when you need it
- To complement your personal financial strategy, we also have 401(k) matching
We offer competitive salary, a comprehensive benefits & relocation package and advancement opportunity.
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.