SENIOR SPECIALIST DUTIES & RESPONSIBILITIESResponsible for managing higher level, more complex GMP validation project activities at the BIAH sites from concept through process validation as outlined by the Site Validation Master Plan (VMP) and Corporate Policies and Procedures.
Maintain site validation database and document systems, support feasibility studies, equipment review, selection, acquisition and upgrade.
Develop and maintain higher level departmental and site standard operating procedures (SOP) and training operations on quality principles.
Support and facilitate strategic direction of validation philosophies, improve overall validation system and process flow incorporating into the Site VMP. Provide oversight and document review for smaller validation projects and routine Validation Maintenance deliverables.
Support Engineering and Maintenance activities associated with Quality Systems.
Preparation of validation protocols, coordinating, scheduling and test execution, for areas including but not limited to Biological Production, QA, QC, Sterile Filling, Packaging & Labeling and Logistics.
Provide peer review for validation protocols and reports.
Maintain calibration status of validation test equipment.
Serve on assigned internal and external project teams (change controls, deviations, technology transfer,) as a technical/compliance resource to solve quality related issues and/or support continuous improvement.
Train Operations personnel in quality and validation principals.
Support Engineering and Production Depts. in the selection, review, acquisition, and upgrade of systems and production equipment. Provide technical support in developing user and functional requirements specifications, URS, FRS, for systems and equipment.
Assist with internal, regulatory or Corporate audits to ensure compliance with domestic and international regulations, quality requirements and guidance documents.
Assist with audit responses and completion of assigned CAPAs by target due dates. Included is the responsibility for making sure Validation areas are 'inspection ready' at all times.
Support Change Control and CAPA activities.
Performs all company business in accordance with all regulations (e.g. USDA, etc.) and Company policy and procedures. Demonstrated high ethical and professional standards with all business contacts to maintain BIAH excellent reputation in the community. When violations are noted or observed, they are immediately reported to management.
PRINCIPAL DUTIES & RESPONSIBILITIES- Responsible for managing higher level, more complex GMP validation project activities at the BIAH US locations from concept through process validation as outlined by BIAH's Validation Master Plan (VMP) and Corporate Policies and Procedures.
- Maintains site validation database and document systems, supports feasibility studies, equipment review, selection, acquisition and upgrade.
- Develops and maintains higher level departmental and site standard operating procedures (SOP) and training on quality principles.
- Promotes staff development and growth, performs training to staff and other departments.
- Leads and actively supports strategic direction of validation philosophies, improve overall validation system and process flow incorporating into BIAH VMP.
- Provides oversight and document review for smaller validation projects and routine Validation Maintenance deliverables.
- Develops and Maintains local standard operating procedures to follow all FDA/EU/USDA regulations, as well as Corporate procedures.
- Serves on assigned internal and external project teams (change controls, deviations, technology transfer) as a technical/compliance resource to solve quality related issues and/or support continuous improvement.
- Trains personnel in quality and validation principals
- Supports Engineering and departments in the selection, review, acquisition, and upgrade of systems and production equipment.
- Provides technical support in developing user and functional requirements specifications, URS, RA FRS and DQ for systems and equipment.
- Participates with internal, regulatory or Corporate audits to ensure compliance with domestic and international regulations, quality requirements and guidance documents.
- Develops and assists with audit responses and completion of assigned CAPAs by target due dates.
- Responsible for ensuring Validation areas are "inspection ready" at all times.
- Supports Change Control, Deviation and CAPA activities
- Performs all company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures.
- Demonstrated high ethical and professional standards with all business contacts to maintain BIAH's reputation in the community.
- Immediately reports noted/observed violations to management.
PRINCIPAL REQUIREMENTBachelor Degree in a relevant scientific, bioengineering or relevant discipline
Six (6) years GMP validation or similar experience in a GMP manufacturing or similar production environment
Minimum of ten (10) years GMP validation experience in a GMP or regulated manufacturing or similar environment in lieu of a degrees.
Experience must be inclusive of at least three (3) years leading projects.
Ability to plan, schedule, organize, prioritize and coordinate project activities.
Ability to function in a leadership role and within cross function teams.
Ability to analyze validation and production data to assess compliance with GMP requirements and/or troubleshoot compliance problems
Excellent written and verbal communication skills
Excellence in comprehension/application of FDA/EU/USDA regulatory requirements for production and distribution of regulated biological articles
Strong theoretical and practical knowledge of regulated processes and one technical discipline, such as biology to apply knowledge or experience to assigned tasks.
Ability to make decisions regarding the acceptability of product based on documentation provided.
Demonstrated ability to work with diverse groups of people and conflict management.
Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook, PowerPoint).
Eligibility Requirements:
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.
