Quality Control Analyst I Job Responsibilities
Education & Qualifications
- Responsible for performing the day-to-day quality operations for the Quality Assurance (QA) department within the Quality organization, including batch record review on the floor and quality inspection activities associated with Packaging and BAXJECT III processes.
- Perform the final review of QA Inspection documentation to support Filled Unlabeled Vial (FUV) and Final Drug Product (FDP) release.
- Identify and assess quality risks in activities and processes according to regulatory agency requirements and guidelines and the client's quality practices.
- Initiate and complete event investigations to identify why a deviation occurred and to minimize/eliminate reoccurrence.
- Revise documents to drive continuous improvement including streamlining processes and maintaining GMP compliance.
- Support departmental projects and any quality working teams when required.
- Responsible for QA Inspection activities associated with visual inspection, assembly, packaging, and label stores management for BaxJect III manufacturing.
- Perform on the floor lot/batch documentation review to ensure compliance with all requirements.
- Initiate and perform nonconformance investigations, which may include assigning root cause, ascertaining material/product impact, and determining appropriate corrective action(s).
- Revise documents to support process improvements, corrective actions, corporate/division compliance, and audit commitments.
- Assist in external and internal audits by maintaining audit records, collecting and creating relevant data reports from databases, and presenting processes during tours.
- Manage activities of self in achieving defined Quality goals in an efficient, accurate and timely
- Support in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and the client's quality requirements.
- Support and drive continuous improvements consistent with the divisional strategy and ensure compliance to all applicable state, federal and international regulations.
- Administer and maintain relevant databases, preparing and issuing reports as defined by the area as well as developing custom reports as needed.
- Must demonstrate strong leadership, influence, and cross-functional collaboration skills and able to work efficiently in a cross-functional team environment.
- Represent department in cross-function projects
- Bachelor's degree in science, engineering or other related technical field strongly preferred. 2+ years of related experience.
- Skilled in use of electronic word processing, spreadsheet, project management, and presentation tools such as Microsoft Office (Word, Excel, Project, PowerPoint).
- Ability to prioritize and thrive in a fast-paced environment.
- May perform other duties as assigned.
- Have strong interpersonal skills
- Have the ability to operate in a dynamic, cross-functional environment.
- Be able to be flexible.
- Result Driven- manufacturing process simplification and also yield improvement ideas, generate breakthrough solutions.
- Be able to have great attention to detail is necessary.
- Be able to handle multiple tasks and projects concurrently
- Have strong organizational skills and the ability to plan, follow-up, and implement tasks.
- Have good critical thinking and problem solving skills (DMAIC, Six Sigma, and Lean).
- GEMBA - good investigational experience who goes to the floor see the actual process where event occurred and who also implement robust Corrective Actions for the correct Root Causes.
- Yellow Belt/Green Belt training/certification preferred.
- Have good verbal and written communication skills.
- Have general knowledge of biotech manufacturing theories and processes.
- Have knowledge of FDA and EMA Regulations, Application of Good Documentation Practices (GDP), and application of current Good Manufacturing Practices (cGMP).
- Be able to perform and analyze trending through the use of DeltaV system.
- Be able to generate spreadsheets and power point presentations on the computer.
- Be able to support departmental / plant goals.
- Be able to review and approve investigations
- Be able to work independently and with intermittent supervision.
- Must be able to work more than 8 hours a day or 40 hours a workweek as required.
- Overtime may be required at times and include weekends and holidays.
- Must be able to work in controlled clean room environment requiring special gowning. requirements include: no jewelry or cosmetics. Special gowning requires complete coverage of head, face, hands, feet and body.
- Possible exposure to cold storage conditions.
- May be around moving equipment and machinery (e.g. forklifts, pallet jack).
- May be required to work or be assigned to a different shift as needed.
- Will have interaction with other people.
- Pace may be fast and job completion demands may be high.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.