Apellis is developing novel therapeutic compounds to treat disease by harnessing the foundational part of the immune system, known as complement. The QA Sr. Specialist will be an integral part of the quality team in the Apellis San Francisco site responsible for day to day quality assurance systems and activities related to GMP compliance of Apellis' contract manufacturers or contract service providers (CSPs) and San Francisco site.
The candidate will ensure timely lot disposition including completing participate and/or oversees disposition of product(s). Primary responsibilities include routine batch record review and compilation of batch histories. Batch record review consists of executed batch records, all associated analytical data, and Quality Events. Assist, perform, compile, and/or review investigations, CAPAs, and change controls related to manufacture of the products at CSPs. Actively work with Technical Operations and CSPs to manage/coordinate receipt, review, and approval of quality documents, ensuring timely batch disposition. Tracks, trends and reports quality metrics.
The candidate is expected to effectively interact with internal multidisciplinary team members, and external contract manufacturing locations, to support product manufacturing and release. Works closely with departments to identify upcoming manufacturing activities and associated timelines for disposition in an effective and efficient manner. Plans, organizes and prioritizes work activities. Communicates delays and works to resolve review discrepancies with manufacturing locations. Identify and communicate quality and compliance risks associated with product batches and coordinate plan to addresses risks.
BASIC EDUCATION & EXPERIENCE:
5+ years of direct experience in batch record review and disposition. CMO management experience is desired.
BA/BS in any Life Science or a related scientific discipline is required with 5+ years' in biopharmaceutical and some medical devices quality operations experience.
Strong knowledge of cGMP regulations, practices and trends pertaining to pharmaceutical product development, manufacturing, and testing.
KNOWLEDGE AND SKILLS:
Judgment - Exhibits sound and accurate judgment; supports and explains reasoning for decisions, includes appropriate people in decision-making process, makes timely decisions
Technical Skills - Pursues training and development opportunities, strives to continuously build knowledge and skills, shares expertise with others and displays willingness to make tough decisions
Quality Values - Demonstrates accuracy and thoroughness, looks for ways to improve and promote quality, carefully monitors work for accuracy, and also applies comprehensive knowledge of quality and GMP principles so as to maintain current understanding of global GMP regulations
Dependability - Follows instructions, responds to management direction, keeps commitments, completes tasks on time and commits to long hours of work when necessary to achieve goals
Multitasking - Ability to handle multiple tasks concurrently and in a timely fashion.
Team - Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
Oral Communication - speaks clearly and persuasively in all situations, good listener and responds well to questions
Written Communication - Writes clearly and informatively and able to read and interpret written information and ability to communicate effectively with peers and management
Ethics - Keeps commitments, inspires trust, works with integrity and upholds Quality values.
Physical Demands and Work Environment:
This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.
This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
Benefits and Perks:
Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!