Quality Assurance - Sr. Analytical Manager

Location
College Station, TX
Posted
Jun 03, 2022
Ref
2022-20306
Hotbed
Lone Star Bio
Required Education
Bachelors Degree
Position Type
Full time

  The Quality Assurance (QA) Analytical Manager, will be responsible for the overall performance of the QA Analytical Group, providing QA oversight of the Quality Control (QC) group.  The Manager will handle all associated responsibilities in compliance with FDB quality policies and site SOPs to ensure regulatory compliance. 

External US

Essential Functions:

 

Leadership

  • Provides QA oversight of QC, ensuring compliance with local and global policies and procedures, together with regulatory requirements
  • Mentors and provides direction to the QA Analytical Group ensuring compliance with local and global quality standards, regulatory requirements, and partner commitments.
  • Develop, motivate, and lead direct reports towards achieving organizational and individual goals.
  • Work collaboratively with management of other site functions to instill a ‘Quality Culture' by coaching in the application of GMP Principles including the underlying rationale of those principles.

Operational Delivery

  • Providing QA support to the compliant and on-time delivery of the QC analytical packages for GMP program introduction and disposition of Drug Substance/Product.
  • Delivery of QA support to the QC stability group to ensure accurate, compliant, and on-time fulfilment of client Stability Programs.
  • Collaborate with client QA to ensure client needs are met whilst maintaining compliance with site Quality Management Systems (QMS)

New Business Growth

  • Support client due diligence and Quality audits as well as regulatory inspections.
  • Work with Quality management to implement and grow phase-appropriate QMS that will enable cGMP manufacture and release of pre-clinical to commercial products.

Compliance

  • Ensure self, and team, have no overdue training, or site actions. Support other QA teams, QC and other functions in completion of site actions.
  • Continuously improve the processes specified in Standard Operating Procedures and Work Instructions operated by self and direct reports whilst still ensuring the operations meet all current regulatory requirements.
  • Provide cGMP guidance to other functions including QC, Manufacturing and Facilities.
  • Utilize investigative techniques to determine root causes of deviations and Out of Specification (OOS) Investigations and identify proper corrective and preventative actions.
  • Review and/or approve basic and technical documentation to include, but not limited to:
  • Standard Operating Procedures
  • Method qualification and validation protocols and reports
  • Deviation Reports, OOS Investigations, Retest Plans, Corrective and Preventive Actions, and Change Controls
  • QC Analytical Data and Certificates of Analysis
  • Product Specifications, Specification Rationales, and Sample Plans
  • Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.

All other duties as assigned.

 

 

Required Skills & Abilities:

  • Excellent written and oral communication skills.
  • Excellent organizational, analytical, data review and report writing skills.
  • Ability to set personal performance goals and provide input to departmental objectives.
  • Develop staff to maximize contributions to the team and the company.
  • Ability to multitask and easily prioritize work.
  • Ability to work independently with little supervision.
  • Proficient in Microsoft Excel, Word and PowerPoint.
  • All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

 

 

  • Experience prolonged standing, some bending, stooping, and stretching.
  • Ability to sit for long periods to work on a computer.
  • Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials.
  • Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
  • Lifting up to 25 pounds on occasion.
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
  • Must be willing to work flexible hours.
  • Ability to work weekends and off-shift hours, as needed to support manufacturing activities.
  • Must be willing to travel occasionally, as needed.
  • Attendance is mandatory.

Qualifications:

  • Master's degree preferably in a science-related field with six (6) years of related experience, and two (2) years of supervisory experience: OR
  • Bachelor's degree preferably in a science-related field with eight (8) years of related experience, and two (2) years of supervisory experience.
  • At least four (4) years of cGMP experience.

Preferred Qualifications:

  • Certified Quality Auditor
  • Degree in Biology, Chemistry

We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. 

If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3500.