Job Description

Job Summary

Manage overall batch review of sterile and OSD manufacturing/packaging records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, instrument preventive maintenance/calibration/qualification/validation as per good manufacturing practices/good documentation requirements and ALCOA++ principles). This role will be an individual contributor with expert level experience in manufacturing investigations from FDA approved facilities that make sterile and OSD products.

Area Of Responsibility

• Subject matter expert (SME) understanding of sterile manufacturing and packaging.
• Leads the review of sterile and OSD manufacturing/packaging records from a Global Quality perspective.
• QA SME for manufacturing (Sterile & OSD), environmental monitoring, microbiology, media-fill & packaging Investigations and related CAPAs.
• Successful experience with FDA inspections
• Ensure that all activities are compliant with Standard Operating Procedure, STP and GP etc.
• Review of equipment qualification, process validation protocols and reports for accuracy, completeness and traceability as well as adherence to the Protocol/procedures.
• Training of colleagues across multiples sites.
• Work in partnership with site Quality Assurance.
• Follow the EHS policy, procedures and maintain the compliance to cGMP requirements.
• Participates and conducts mock inspections to prepare the facility for audits and assesses gaps in the system; review documents for compliance to current regulations and cGMPs.
• Identifies compliance concerns and supports continuous improvements.
• Performs additional assignments as needed.

Work Conditions:

Corporate Office Environment

Manufacturing / Production Environment

Laboratories

Warehouse Environment

Field Familiarity Environment

Travel Estimate

• Up to 30 %

Education and Job Qualification

• Minimum of Bachelor’s degree
• Thorough understanding of GMPs, specifically those relating to good documentation practices
• Expertise in software applications such as: MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Acrobat Reader, TrackWise, LMS (Learning Management System) etc.
• Knowledge of project management principles, practices, techniques and tools
• Strong communication, interpersonal and organizational skills
• The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR)

Experience

• Minimum of five (5) years of experience within the pharmaceutical industry
• Subject matter expert (SME) in sterile manufacturing and packaging required
• Ability to the review of sterile and OSD manufacturing/packaging records from a Global Quality perspective.
• QA SME for manufacturing (Sterile & OSD), environmental monitoring, microbiology, media-fill & packaging Investigations and related CAPAs
• Experience working in an international, multicultural matrix organization

The presently-anticipated base compensation pay range for this position is $111,000 to $135,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.