Overview
Remote
On Site
Hybrid
$36.6 - $38.9 hr
Contract - Independent
Contract - W2
Contract - 18+ mo(s)
Skills
QUALITY CONTROL
QC
CAPA
NON CONFORMANCE
NC
CHANGE CONTROL
SAP
QUALITY
RAW MATERIALS
RAW MATERIAL
Job Details
Payrate: $36.60 - $38.90/hr.
Summary:
Under general supervision, this position will perform routine procedures (i.e., NC/CAPA/CC) and process improvements projects to support Corporate Quality Control. Specific responsibilities include performing investigations to support corrective actions, procedures revision, Training portfolio, monitoring and revising SAP Mater data Quality Inspection plans, and projects implementation plan. Will also be responsible for documenting, computing, compiling, interpreting, reviewing and entering data. Additional responsibilities include providing and communicating results, maintaining global process trackers, develop project plan, support Business Continuity and Risk Management objectives, and initiating and/or implementing changes in controlled documents. Must learn and comply with safety guidelines, and cGMPs/CFRs which includes, but is not limited to, the maintenance of Corp QC training portfolio, training records, multisite procedures, CAPA/Change control records, written procedures and general support to Corporate QC improvements projects.
Responsibilities:
Qualifications:
Desired Skills:
Pay Transparency: The typical base pay for this role across the U.S. is: $36.60 - $38.90 /hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (;/span>
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
Summary:
Under general supervision, this position will perform routine procedures (i.e., NC/CAPA/CC) and process improvements projects to support Corporate Quality Control. Specific responsibilities include performing investigations to support corrective actions, procedures revision, Training portfolio, monitoring and revising SAP Mater data Quality Inspection plans, and projects implementation plan. Will also be responsible for documenting, computing, compiling, interpreting, reviewing and entering data. Additional responsibilities include providing and communicating results, maintaining global process trackers, develop project plan, support Business Continuity and Risk Management objectives, and initiating and/or implementing changes in controlled documents. Must learn and comply with safety guidelines, and cGMPs/CFRs which includes, but is not limited to, the maintenance of Corp QC training portfolio, training records, multisite procedures, CAPA/Change control records, written procedures and general support to Corporate QC improvements projects.
Responsibilities:
- Provide summary reports, data analysis and ensure flow of communication between RM Networks including following up and resolving issues that arise.
- Provide expert support to RM IQA network.
- Coordinates, manages, and performs changes to the multisite documents or in response to change requests approved by management.
- Work within the Information Services and Quality Systems teams to foster good communication throughout the project life cycle.
- Ensure compliance - which includes implementing procedures that enhance GMP and safety.
- Manage existing and/or develop and implement new programs, processes and methodologies
- Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
- Support of investigations and corrective actions.
- May serve as subject matter expert to develop technical training.
- May perform routine work in a specific area of responsibility as necessary.
- Represents the department/organization on various team.
- Independently responsible for following through on multi-site action items.
- May interact with regulatory agencies regarding area(s) of responsibility including written responses.
- May resolve issues with outside resources.
- Performs special projects as requested by supervisor.
- Available to work overtime or weekends to conduct any special assignment as per business request.
Qualifications:
- Doctorate degree in Science or Chemistry, or master s degree in science or chemistry & 3 years of directly related experience or Bachelor s degree in science or chemistry & 5 years of directly related experience
- Project management skills (for network project support & communication)
- GMP regulations experience for Quality Systems documentation (Change control/CAPA/Training etc.)
- SAP Quality Management Module knowledge & experience
- Raw materials quality manager experience
Desired Skills:
- Understand, support and demonstrate the values.
- Excellent communication skills, facilitation and presentation skills.
- Excellent technical writing skills.
- Strong computer operation skills including Word processing, presentation, database and spreadsheet application skills.
- Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion.
- Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.
- Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.
- Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility.
- Knowledge of pharmaceutical processes.
- Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products.
- Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products.
- Extensive knowledge and application of GMPs/CFRs.
- Ability to evaluate compliance issues. Skill in evaluating and documenting according to Company and various guidelines.
- Proficient at maintenance, troubleshooting and operation of equipment in area of expertise.
- Extensive knowledge and application of SAP Quality Management (QM) Module
- Advanced skills in solving complex problems.
- Advanced data trending and evaluation.
- Strong skill in working independently and to effectively interact with various level.
- Ability to interact with regulatory agencies both orally and in writing.
- Initiate, coordinate and lead cross functional team.
- Excellent skill in leading, motivating, influencing, and negotiating.
Pay Transparency: The typical base pay for this role across the U.S. is: $36.60 - $38.90 /hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (;/span>
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.