Senior Quality Assurance Specialist I

Date: Jul 24, 2024

Location: Eugene, OR, US, 97402

Company: Actylis

Actylis is a leading manufacturer and supplier of critical raw materials and performance ingredients serving the Life Sciences, Specialty Chemicals, and Agriscience industries.

 

We offer standard and custom ingredients through our rapidly growing portfolio of GMP and non-GMP facilities worldwide, and further choice through our strong sourcing hub network. This unique hybrid option blending manufacturing and global sourcing, combined with more than 75 years of sourcing and distribution experience makes Actylis the Partner of Choice.

Position Summary

A Senior Quality Assurance (QA) Specialist has operational responsibility of policies, procedures, and documentation to maintain compliance and alignment with current regulatory guidance and regulations.  The ideal candidate is one who thrives working in a highly dynamic, team-oriented environment, sharing the common goal of maintaining a robust Quality Management System (QMS) for a GMP Pharmaceutical Production Facility. The Senior QA specialist’s role is expected to provide guidance and support to other QA specialists in a mentoring capacity.

Responsibilities will include:

•    Review of batch records, logbooks, laboratory notebooks, Certificates of Analysis (CofA) and other Quality related documentation
•    Create and revise quality assurance policies and procedures.
•    Work collaboratively with other departments to conduct deviation investigations and write reports.
•    Provide QA review of excursion/non-conformances, deviations, OOT, OOS, and CAPA Reports. 
•    Track and trend Key Performance Quality Indicators (KPQIs) 
•    Review and approve method transfer, specifications, validation protocols, and summary reports.
•    Review and approve supplier, service provider, and subcontractor surveys.
•    Assist in customer audits, regulatory inspections and conduct internal audits.
•    Participate in preparation of response to client audit and regulatory inspection.   
•    Generate batch records, shipping documentation, logbooks, and other Quality related materials.
•    Serve as Quality representative on assigned client projects.
•    Understand and apply ICH, USP, FDA, EU and ISO standards and guidance effectively.
•    Train and provide mentorship to co-workers as needed.
•    May act as an interim Supervisor in the absence of the QA Manager as assigned by the QA Director.

Required Experience & Knowledge

Education Requirements:
•    Minimum of B.S. degree in a physical science discipline (preferably Chemistry or Biochemistry) with 7 years of applicable industry

     experience, or M.S. degree with 5 years of experience, or PhD with 3 years of experience.
•    Preferred: M.S. degree in a physical science discipline

     (preferably Chemistry or Biochemistry) with 5+ years of applicable industry experience.
•    GMP Exposure and auditing experience preferred. 
•    Preferred certification such as CQA from ASQ.

Skills:

•    Must be proficient in reviewing executed batch records, and data associated with a variety of analytical techniques including, but

     not limited to, analytical balances, pH meters, HPLC, LCMS, GC, GCMS, FTIR, UV/Vis spectroscopy, and moisture analysis by

     Karl Fischer.
•    Demonstrate skills to review data packets for technical and regulatory compliance errors.
•    Demonstrate skills to write scientifically sound investigations of deviations and OOS events.
•    Demonstrate ability to effectively follow good documentation policies.
•    Must be willing to work both independently and as a team player with a positive attitude.
•    Detail-oriented mindset with excellent critical thinking, multi-tasking, and organizational skills.
•    Clear, effective, and professional communication with colleagues, clients, and contractors
•    Demonstrate considerate and safe behaviors in laboratory and manufacturing suits
•    Effective time management strategies to ensure work is performed within required timelines
•    Stay current with pharmaceutical industry regulatory requirements and standards.

Physical Requirements and Work Environment

•    Works in an office, GMP production suite and laboratory environment
•    Must be able to work safely with chemicals and hazardous materials

•    May sit or stand for long periods of time
•    May lift up to 40 pounds with or without reasonable accommodation

•    May work at both Actylis sites in Eugene and may travel between sites as needed

 

Actylis is an Equal Opportunity Employer. Actylis US does not discriminate on the basis of race, religion, color, sex, gender identity or perception, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided based on qualifications, merit, and business need.


Nearest Major Market: Eugene