Sr. Quality Assurance Specialist - GMP , RA

Alcami Corporation•Durham, NC

3d•Hybrid

About The Position

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures. These activities may include reviewing documents and data, conducting audits and inspections, hosting audits and inspections, and maintaining quality databases. The ideal candidate will assist internal teammates and partner with individuals from other departments for the development of SOPs and associated documents, and process improvements. The Sr. Quality Assurance Specialist will provide guidance and mentoring to Operations personnel in achieving a high level of GMP compliance and instilling quality culture. On-Site Expectations Hybrid role with 3 days per week expected on-site. 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Requirements

Bachelor’s degree in Chemistry, Biology, or related field with 10+ years of GMP related experience, or Master’s degree in related field.
Minimum five years of related work experience.
Aseptic parenteral manufacturing or oral solid dosage form manufacturing.
GMP and Annex 1 experience.
Good writing and communication skills.
Proficient in regulatory submissions (IND, ANDA, NDA, BLA, NADA).

Responsibilities

Provide regulatory expertise and strategy for clients on their products and services.
Performs quality/regulatory review and approval of documents, data, protocols, and/or reports.
Performs negotiations for new quality agreements.
Represents regulatory in intracompany meetings and client meetings.
Maintains licenses and current registrations.
Supports internal quality audits and/or inspections.
Supports client audits and inspections, and regulatory inspections and responses.
Maintains regulatory databases.
Assists with implementation and supports quality systems, including but not limited to, operations support, training, vendor management, and overall regulatory inspectional readiness.
Assists with quality improvement initiatives as needed.
Assists with development of SOPs or other quality documents.
Maintains accurate files and records.
Serves as an effective member of the Quality Assurance team and may serve as a mentor to others in area of expertise.
Complies with company polices and SOPs.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Other duties as assigned.