USAntibiotics, LLC
Overview
USAntibiotics, the only U.S. manufacturer of Amoxicillin products, is part of the Jackson Healthcare family of companies. We'Re always looking to add new talent to our teams, and we value diverse professionals who have strong leadership skills, align with our culture, and are committed to excellence.
POSITION SUMMARY:
Provide specialized technical support within the Quality Assurance Laboratory as assigned.
Provide leadership/training to less experienced staff, as assigned to assure efficient and valid analytical laboratory support the Bristol site.
Assist with supervisory duties in the absence of Management (including review and approval of analytical data per cGMPs and regulatory requirements).
Perform analytical testing of all sample types as assigned.
Assist with development and validation of chemical assays.
Lead installation, validation and troubleshooting new and existing equipment, including automated systems, as assigned.
Assist Management in improving efficiency and compliance status of laboratories.
Roles & Responsibilities
Perform technical duties in specialized area or function as leader in absence of management, as assigned. Assist laboratory supervisors with tasks, as needed
Perform efficient and reliable analytical tests following validated procedures for a wide variety of methods and sample types as assigned
Document all results in accordance with cGMPs and written procedures
Trouble-shoot and solve problems with assays and equipment with little or no supervision. Report all observations
Recommend changes to methods and operations as appropriate
Interpret analytical results correctly, notifying Management promptly of both situations that indicate analytical issues and manufacturing or product issues
Develop/implement appropriate corrective and preventative actions (CAPA)
Maintain the QC laboratories to comply with cGMP and Dr Reddy's standards of safety, quality, and cleanliness
Participate in analytical method validations or transfers as required
Perform satisfactorily on all analyst qualification studies, indicating technical proficiency
Plan, perform, and document non-routine tests (or special studies) and investigations under the direction of Manager
Evaluate and utilize state-of-the-art equipment including automated systems and computerized systems to perform testing and meet the goal of improved assay performance, including reliability , cost and assay characteristics
Maintain and improve proficiency of operations through training
Write validation reports, analytical procedure SOPs and equipment SOPs as required
Notify Management of any SOPs that may require revision and initiate change requests per written policy, providing sufficient evidence/documentation to support change request
Conduct special studies in accordance with protocols and direction of management. Prepare well documented reports of results
Carry out other departmental duties as deemed appropriate by supervisor/manager
Broaden understanding of subtleties of the techniques utilized by keeping current with technical and professional literature, attending technical discussions both inside and outside the Dr Reddy's community
Provide technical and professional expertise to less experienced staff in the laboratory
Serve as technical resource during Regulatory inspections and internal audits as required. Also, conduct internal audits and self-inspections as required. Provide information to outside vendors and technical representatives in a professional manner
Review (i.e., validate) and approve analytical results for other laboratory personnel as assigned
Assist management in conducting analytical failure investigations, as required, following all procedures
Responsible for calibrating and maintaining assigned laboratory equipment according to schedules and procedures, documenting all results
Lead equipment qualifications, drafting protocols and summary reports, as directed by management
Specialized area of responsibility as assigned
Analytical Methodology/Instrumentation Mastery
LIMS
SAP
Compendial/Regulatory Expertise
QUALIFICATIONS - EDUCATION, WORK EXPERIENCE, CERTIFICATIONS
BS/BA degree in Chemistry (or related science) or equivalent related analytical experience
PREFERRED QUALIFICATIONS
Master's Degree in Chemistry (or related science) and/or approximately 7 years scientific work experience, which includes a specialized skill
Previous pharmaceutical industry experience
EXPERIENCE REQUIRED
Minimum of 5-10 years of analytical experience in pharmaceutical industry and/or other scientific experience
Strong knowledge/experience of cGMPs in areas beyond QC laboratory
KNOWLEDGE, SKILLS, AND ABILITIES
Demonstrated ability to perform a wide variety of chemical, instrumental, and chromatographic analyses
Demonstrated mastery of skills at Chemist level and/or expertise in specific topic
Advanced computer skills
Advanced method development and trouble-shooting skills
Thorough understanding of chemical theory on which test methodology is based with strong laboratory testing skills
Appropriate interpersonal and leadership skills
Advanced verbal and written communication skills
Ability to prioritize and decide appropriate course of actions. Consistently notifies Management of possible compliance and technical issues and suggests/implements corrective actions
Ability to handle multiple priorities efficiently and make/implement decisions
Fully versed in cGMPs, FDA, and other regulatory agency requirements
Ability to function independently on special projects and follow through to successful completion
Ability to maintain confidentiality
Ability to work in a team multi-disciplinary environment interacting on a professional level with peers, subordinate and senior personnel
ACCOUNTABILITY
Assures that testing of products manufactured at the facility is performed per approved procedures and appropriate regulations and that lab operations conform to company standards for safety and performance
Performs technical functions based on mastery of specialized topic, and advises/assists less experienced personnel in the laboratories
Assures the quality of laboratory documentation, i.e., documentation is comprehensive and accurate
Provides leadership in the laboratory in the absence of Management and make appropriate decisions regarding product release and quality
Assists laboratory supervisors with duties, as needed
COMPLEXITY
Serves as backup to management for routine lab operations and in planning laboratory investigations, determining validity of results and appropriate actions
Advises in a technical role less experienced staff, notifying Management of problems/issues or additional training needs
Performs statistical analysis as required for annual product reviews, special studies, investigations, etc. Also must use judgement to raise possible issues to upper management
Initiates operational changes in laboratory, within constraints of policies and procedures to improve cGMP compliance, efficiency, cost, and performance
Assures the integrity of analytical results/documentation generated
Assists the Quality Assurance Department in meeting goals established
TRAVEL REQUIREMENTS & WORKING CONDITIONS
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
While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; write; type; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and smell
The employee must frequently lift and/or move up to 50 pounds
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
EEO Statement We are an Equal Opportunity Employer and do not discriminate based on race, color, religion, sex, national origin, age, disability, veteran status, or any other protected status under the law.
#J-18808-Ljbffr
POSITION SUMMARY:
Provide specialized technical support within the Quality Assurance Laboratory as assigned.
Provide leadership/training to less experienced staff, as assigned to assure efficient and valid analytical laboratory support the Bristol site.
Assist with supervisory duties in the absence of Management (including review and approval of analytical data per cGMPs and regulatory requirements).
Perform analytical testing of all sample types as assigned.
Assist with development and validation of chemical assays.
Lead installation, validation and troubleshooting new and existing equipment, including automated systems, as assigned.
Assist Management in improving efficiency and compliance status of laboratories.
Roles & Responsibilities
Perform technical duties in specialized area or function as leader in absence of management, as assigned. Assist laboratory supervisors with tasks, as needed
Perform efficient and reliable analytical tests following validated procedures for a wide variety of methods and sample types as assigned
Document all results in accordance with cGMPs and written procedures
Trouble-shoot and solve problems with assays and equipment with little or no supervision. Report all observations
Recommend changes to methods and operations as appropriate
Interpret analytical results correctly, notifying Management promptly of both situations that indicate analytical issues and manufacturing or product issues
Develop/implement appropriate corrective and preventative actions (CAPA)
Maintain the QC laboratories to comply with cGMP and Dr Reddy's standards of safety, quality, and cleanliness
Participate in analytical method validations or transfers as required
Perform satisfactorily on all analyst qualification studies, indicating technical proficiency
Plan, perform, and document non-routine tests (or special studies) and investigations under the direction of Manager
Evaluate and utilize state-of-the-art equipment including automated systems and computerized systems to perform testing and meet the goal of improved assay performance, including reliability , cost and assay characteristics
Maintain and improve proficiency of operations through training
Write validation reports, analytical procedure SOPs and equipment SOPs as required
Notify Management of any SOPs that may require revision and initiate change requests per written policy, providing sufficient evidence/documentation to support change request
Conduct special studies in accordance with protocols and direction of management. Prepare well documented reports of results
Carry out other departmental duties as deemed appropriate by supervisor/manager
Broaden understanding of subtleties of the techniques utilized by keeping current with technical and professional literature, attending technical discussions both inside and outside the Dr Reddy's community
Provide technical and professional expertise to less experienced staff in the laboratory
Serve as technical resource during Regulatory inspections and internal audits as required. Also, conduct internal audits and self-inspections as required. Provide information to outside vendors and technical representatives in a professional manner
Review (i.e., validate) and approve analytical results for other laboratory personnel as assigned
Assist management in conducting analytical failure investigations, as required, following all procedures
Responsible for calibrating and maintaining assigned laboratory equipment according to schedules and procedures, documenting all results
Lead equipment qualifications, drafting protocols and summary reports, as directed by management
Specialized area of responsibility as assigned
Analytical Methodology/Instrumentation Mastery
LIMS
SAP
Compendial/Regulatory Expertise
QUALIFICATIONS - EDUCATION, WORK EXPERIENCE, CERTIFICATIONS
BS/BA degree in Chemistry (or related science) or equivalent related analytical experience
PREFERRED QUALIFICATIONS
Master's Degree in Chemistry (or related science) and/or approximately 7 years scientific work experience, which includes a specialized skill
Previous pharmaceutical industry experience
EXPERIENCE REQUIRED
Minimum of 5-10 years of analytical experience in pharmaceutical industry and/or other scientific experience
Strong knowledge/experience of cGMPs in areas beyond QC laboratory
KNOWLEDGE, SKILLS, AND ABILITIES
Demonstrated ability to perform a wide variety of chemical, instrumental, and chromatographic analyses
Demonstrated mastery of skills at Chemist level and/or expertise in specific topic
Advanced computer skills
Advanced method development and trouble-shooting skills
Thorough understanding of chemical theory on which test methodology is based with strong laboratory testing skills
Appropriate interpersonal and leadership skills
Advanced verbal and written communication skills
Ability to prioritize and decide appropriate course of actions. Consistently notifies Management of possible compliance and technical issues and suggests/implements corrective actions
Ability to handle multiple priorities efficiently and make/implement decisions
Fully versed in cGMPs, FDA, and other regulatory agency requirements
Ability to function independently on special projects and follow through to successful completion
Ability to maintain confidentiality
Ability to work in a team multi-disciplinary environment interacting on a professional level with peers, subordinate and senior personnel
ACCOUNTABILITY
Assures that testing of products manufactured at the facility is performed per approved procedures and appropriate regulations and that lab operations conform to company standards for safety and performance
Performs technical functions based on mastery of specialized topic, and advises/assists less experienced personnel in the laboratories
Assures the quality of laboratory documentation, i.e., documentation is comprehensive and accurate
Provides leadership in the laboratory in the absence of Management and make appropriate decisions regarding product release and quality
Assists laboratory supervisors with duties, as needed
COMPLEXITY
Serves as backup to management for routine lab operations and in planning laboratory investigations, determining validity of results and appropriate actions
Advises in a technical role less experienced staff, notifying Management of problems/issues or additional training needs
Performs statistical analysis as required for annual product reviews, special studies, investigations, etc. Also must use judgement to raise possible issues to upper management
Initiates operational changes in laboratory, within constraints of policies and procedures to improve cGMP compliance, efficiency, cost, and performance
Assures the integrity of analytical results/documentation generated
Assists the Quality Assurance Department in meeting goals established
TRAVEL REQUIREMENTS & WORKING CONDITIONS
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
While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; write; type; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and smell
The employee must frequently lift and/or move up to 50 pounds
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
EEO Statement We are an Equal Opportunity Employer and do not discriminate based on race, color, religion, sex, national origin, age, disability, veteran status, or any other protected status under the law.
#J-18808-Ljbffr