Alcami Corporation · 23 hours ago
Quality Specialist - 2nd Shift
Wilmington, NC
Full-time
Onsite
Mid Level
3+ years expAlcami Corporation is a company that delivers reliable solutions for transformative medicines. The Quality Specialist will provide site quality support and ensure compliance with regulatory requirements by reviewing documents, supporting audits, and maintaining quality databases.
Pharmaceuticals
Responsibilities
Performs quality review and approval of complex documents, all types of data, protocols, and/or reports
Supports quality floor audits and/or floor inspections
Performs high volume of AQLs
Performs room start ups
Performs material and component release for production use
Performs work in a Tyvek and full PAPR for startups and AQLS
Supports for client and regulatory agency audits and inspections
Provides quality evaluation and release of support materials, products, equipment and facilities as required
Maintains quality databases and may perform analysis and trending
Assists with quality improvement initiatives as needed
Develops quality SOPs or other quality documents and/or reports as needed
Provides consultation on complex quality and compliance topics in areas of expertise
Develops and provides training in quality and compliance topics in areas of expertise
Provides Quality oversite for the site specific Quality Management Systems including Investigations, Corrective Actions, Change control, etc
Effectively performs a variety of complex duties, on schedule, with accuracy and competency
Maintains accurate files and records
Ensures timely completion and compliance with cGMP and all other relevant company training requirements
Other duties as assigned
Qualification
Required
Bachelor's degree in Chemistry, Biology, or relevant field and 3+ years of related experience required, or Master's degree in relevant field and 1+ years of related experience
Relevant GMP experience required
Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise
Good written and oral communication skills
Good math skills
Good computer skills and knowledge of Microsoft Office products
Ability to be trained and to mentor
Ability to act independently
Ability to interact well with clients and regulatory agents
Ability to negotiate
Ability to interact well with employees at all levels
Ability to act as technical consultant
Uses professional concepts and company policies and SOPs to solve a variety of problems
Receives minimal instruction on day-to-day work, general instructions on new assignments
Company
Alcami Corporation
Alcami is a US-based contract development and manufacturing organization headquartered in NC with 45+ years of experience advancing pharmaceuticals and biologics from development to delivery.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase