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Specialist Quality Complaints , Biopharma (JP11994)
Thousand Oaks, CA · Biotech/PharmaceuticalJob Title: Specialist Quality Complaints, Biopharma (JP11994)
Location: Thousand Oaks, CA. 91320
Business Unit: Final Product Quality & Surveillance
Employment Type: Contract
Duration: 3 years (with possible conversion to permanent)
Rate: $42 - $45/hour W2
Posting Date: 12/11/2023
Notes: Only qualified candidates need apply.
3 Key Consulting is recruiting a Specialist Quality Complaints for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
Under general direction, the Specialist Quality Complaints functions as the Chromatography Data System (CDS) Business Administrator, working with the Biochemistry QC HPLC laboratory. Implement CDS related improvements, including but not limited to development, validation, troubleshooting, documentation, change control and system administration in compliance with client and regulatory standards. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.
Top Must Have Skill Sets:
Day to Day Responsibilities:
Basic Qualifications:
Preferred Qualifications:
Why is the Position Open?
Supplement additional workload on team
Red Flags:
Interview Process:
One phone and one virtual panel interview.
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Location: Thousand Oaks, CA. 91320
Business Unit: Final Product Quality & Surveillance
Employment Type: Contract
Duration: 3 years (with possible conversion to permanent)
Rate: $42 - $45/hour W2
Posting Date: 12/11/2023
Notes: Only qualified candidates need apply.
3 Key Consulting is recruiting a Specialist Quality Complaints for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
Under general direction, the Specialist Quality Complaints functions as the Chromatography Data System (CDS) Business Administrator, working with the Biochemistry QC HPLC laboratory. Implement CDS related improvements, including but not limited to development, validation, troubleshooting, documentation, change control and system administration in compliance with client and regulatory standards. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.
Top Must Have Skill Sets:
- 3+ years of quality and manufacturing experience in biotech or pharmaceutical industry
- Bachelor’s Degree in a Science Field
- Ability to oversee multiple projects simultaneously
- Ability to successfully manage workload to timeliness
- Must be able to defend experience outlined in resume eloquently.
Day to Day Responsibilities:
- Reviewing and acknowledging information contained in product complaint records
- Determining if additional information is required to assign appropriate investigation requirements
- Determining if return samples are required and following its status
- Reviewing and approving assessments supporting the investigation
- Conducting and leading cross functional team meetings to determine investigation requirements to be assigned based on event
- Completing historical data analysis and trend evaluation assessments
- Voiding records if required
- Completing customer feedback records if required
- Own consolidated/trend investigations until closure, if required
- Responsible for the business administration of the Empower CDS, providing technical guidance and support to any related request.
- Provide reports, data analysis and ensure flow of communication between technical groups including following up and resolving issues that arise.
- Provide expert support to Laboratory Applications link to CDS.
- Coordinates, manages, and performs changes to the CDS plan 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.
- Resolve technical issues and troubleshoot for assays as necessary.
- Ensure lab compliance which includes implementing procedures that enhance GMP, GLP 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 laboratory investigations related to chromatography technology.
- 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.
- *Other functions that may be assigned
Basic 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.
- Understand, support and demonstrate the client values.
- Excellent communication skills, facilitation and presentation skills.
- Excellent technical writing skills.4. Strong computer operation skills including Word processing, presentation, database and spreadsheet application skills.
- Hands on experience using CDS, specifically Empower system.
- Strong knowledge as template builder in Empower, including development of custom fields calculations.
- 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.
- Advanced scientific data analysis and interpretation skills.
- 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.
Preferred Qualifications:
- Major in Chemistry with approved Computer Sciences courses
- Must have Strong knowledge as template builder in Empower, including development of custom fields calculations
Why is the Position Open?
Supplement additional workload on team
Red Flags:
- Ensures quality of complaint records, consolidated / trend investigations
- Facilitate cross-functional meetings to plan and coordinate the plan for closure of records
- Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information
- Executes against prioritized work plans
- Quickly escalates issues that could impede the ability to close records according to action plans
- Maintains compliance with local and global processes
- Follows procedures and regulatory requirements
Interview Process:
One phone and one virtual panel interview.
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Regards,
3KC Talent Acquisition Team