Education And Training Jobs in Flemington
60 positions found
Joining us as an Associate Team Leader, you'll support a single retail office during tax season to consistently exceed client expectations and provide daily operations direction for the tax office. You'll begin working a flexible part-time schedule in late fall as you ramp up for the busy tax season and transition to a full-time schedule from January through April.
It would be even better if you also had:
- Experience supervising or managing people
- History of delivering outstanding customer experiences
What you'll bring to the team:
- Support the Multi-Unit Team Leader, serving as an onsite point of contact for tax office associates and clients, ensuring quality and consistent execution that will allow us to promote the value of H&R Block
- Execute and hold all tax office associates accountable to the client service experience, with escalation to the Multi-Unit Team Leader and District General Manager as necessary
- Serve as point of contact for onsite escalated client service concerns
- Ensure clients are scheduled properly and conflicts are resolved, with escalation to the Multi-Unit Team Leader and District General Manager as necessary
- Lead the office from the front desk, providing phone coverage and engaging with clients to deliver an outstanding experience
- Lead daily activities to ensure that all tax office associates are scheduled, and work is completed according to deadlines, with attention to quality standards, priorities and overall goals
- Lead daily huddles and communicate essential information to office associates
Your expertise:
- Prior experience working in customer service or similar role
- Strong organizational skills and ability to plan and manage day-to-day office operations
- Customer-centric mindset and strong communication skills
- Computer proficient with the ability to use MS Office
- Demonstrated ability to work independently with minimal supervision
- Able to work a flexible work schedule of 40 hours per week and flexibility based on business needs
- High school diploma / equivalent or higher
Why work for us:
- Employee Assistance Program with Health Advocate.
- Wellbeing program, BetterYou, to help you build healthy habits.
- Neurodiversity and caregiver support available to you and your family.
- Various discounts on everyday items and services.
- Benefits with additional eligibility requirements: Medical Coverage, 401k Retirement Savings Plan and Employee Stock Purchase Plan.
The community you will join:
At H&R Block we remain committed to building a Connected Culture one in which trust, care, and connections are how we work together as we continue to create an environment where everyone feels safe to bring their authentic self to work every day and feels like they belong as part of a larger team.
You will be immersed in an exceptional work environment that is recognized throughout the world on Best Companies lists! You will also be surrounded by colleagues who are committed to helping each other grow and support each other.
H&R Block is an equal opportunity employer. We welcome and celebrate diversity in the workplace regardless of gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, or veteran status.
If you're looking to make an impact, H&R Block is the place for you.
Pay Range Information
The pay range for this position is listed below. Local minimum wage laws apply. This information is posted pursuant to local requirements to provide applicants with information about what they might be eligible to receive. Individual pay decisions will depend on job-related factors such as experience, education, skill, performance, and geographic location where work will be performed. Successful candidates may be able to participate in one or more incentive compensation or short-term incentive plans, which could generate additional earnings in accordance with the terms of each plan. Qualifying associates can enroll themselves and/or their eligible dependents in medical and prescription drug coverage; can participate in the H&R Block Retirement Savings Plan (401(k) Plan), the Employee Assistance Program, (virtual) fitness center programs, and the associate discount program; are automatically enrolled in Business Travel Accident Insurance; and receive Associate Tax Prep benefit.
Pay Range
$11.00 - $29.00/Hr.
Sponsored Job #28112
Essential Functions of the job:
- Review and validate QC data and test records.
- Support investigations related to Out of Specification (OOS), Out of Trend (OOT), and Out of Expectation (OOE) results.
- Ensure compliance with current Good Manufacturing Practices (cGMP) in the laboratory.
- Assist in the technical documentation of investigations and change control assessments to evaluate the impact on product quality, in alignment with FDA/EU regulations, international standards
- Undertake other duties as required.
This position is ideal for candidates who are detail-oriented and committed to quality assurance in the pharmaceutical industry.
Education/Experience Required:
- Bachelor’s Degree or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline. Scientific degree (ideally chemistry, biochemistry, biotechnology or related).
- Minimum 4 years working experience in an FDA-regulated biotechnology or pharmaceutical company is required.
- Working knowledge and experience with chemistry analytical methods such as HPLC, GC, TOC, Capillary Electrophoresis (CGE-Reduced, CGE-Non-Reduced, and Capillary Zone Electrophoresis), etc.
- Strong working knowledge with USP/EP and cGMP/EU GMP.
- Technical writing experience.
- Familiar with instrument and equipment validation.
- Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
- Credible and confident communicator (written and verbal) at all levels.
- Strong analytical and problem-solving ability.
- Hands-on approach, with a ‘can do’ attitude.
- Ability to prioritize, demonstrating good time management skills.
- Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
- Self-motivated, with the ability to work proactively using own initiative.
- Committed to learning and development
- Self-motivated, with the ability to work proactively using own initiative.
Computer Skills:
- Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
Travel:
- Must be willing to travel approximately 10%.
- Ability to work on a computer for extended periods of time.
Job Title: Data Entry - 2
Location: Whitehouse Station, NJ
Duration: 3 Months (Contract to Hire-CTH)
No. of Positions: 1
Job schedule-This role is now 5 days in office
Job hours-8:00am-4:30pm
Interview process- All interviews will be via WEBEX
Summary:
The main function of this role is the data entry (along with verification and self-review) of policy information via proprietary computer systems. The right person will be responsible for the timely and accurate entry of information/risk/policy characteristics; adhering to documented processes with the ability to meet quality goals and production goals while applying a high level of personal project management skills.
Job Responsibilities:
• Review client/insured data from one proprietary main frame system and transfer data to a second proprietary main frame system.
• Compile and verify the accuracy of data before it is entered.
• This includes ensuring accurate entry of existing data along with the ability to apply the appropriate/ matching additional coverages.
• Individual needs to be able to represent the company in addressing referral reasons/instances with agents and internal customers.
• Within 90 days of hire, reach a quality goal of 80% (with further progression to 95% within 150 days). At the same time, reach an established production goal of 60% within 90 days of higher (with further progression to 90% within 150 days. Review and correct any errors within 24hours of return from the team specialist and/or trainer.
Skills:
• Technical skills include Windows 10 operating platform; ability to research policy information from one proprietary mainframe and system and enter the data into a second proprietary system. A basic operating understanding of Microsoft Office tools (Outlook, Excel, Access and Word) as these tools are used in our daily processes for email communication and tracking. This would not include creation of new spreadsheets or tracking forms as tools are pre-existing. The individual will need to update existing tracking documents to manager their assigned work as well as managing their calendar.
• Verbal and written communication skills, attention to detail, and interpersonal skills.
• Individual will need to accurately document data and follow established process procedures with a general understanding of where to locate all information necessary to complete the process.
• Must be able to multi-task and follow procedures.
• Ability to work both independently and as an engaged member of the team; and manage one’s time.
Education/Experience
• Previous experience with:
o Windows 10 operating system.
o Working knowledge of Microsoft Word (how to create Word Document and attach to an email).
o Basic understanding of a pre-existing Excel spreadsheet.
• computers and applications such as Microsoft Word and Excel. Please be specific on what knowledge is needed for Work and Excel
• Education/Experience: High school diploma or GED required.
• Minimum 2 years of office / business experience. Personal Lines Insurance knowledge and plus.
Job Title: Data Entry - 2
Location: Whitehouse Station, NJ 08889
Duration: 3 Months (CTH)
Job schedule-This role is now 5 days in the office
Job hours: 8:00 am-4:30 pm
Summary:
The main function of this role is the data entry (along with verification and self-review) of policy information via proprietary computer systems. The right person will be responsible for the timely and accurate entry of information/risk/policy characteristics; adhering to documented processes with the ability to meet quality goals and production goals while applying a high level of personal project management skills.
Job Responsibilities:
• Review client/insured data from one proprietary mainframe system and transfer data to a second proprietary mainframe system.
• Compile and verify the accuracy of data before it is entered.
• This includes ensuring accurate entry of existing data along with the ability to apply the appropriate/ matching additional coverages.
• Individual needs to be able to represent the company in addressing referral reasons/instances with agents and internal customers.
• Within 90 days of hire, reach a quality goal of 80% (with further progression to 95% within 150 days). At the same time, reach an established production goal of 60% within 90 days of higher (with further progression to 90% within 150 days. Review and correct any errors within 24hours of return from the team specialist and/or trainer.
Skills:
• Technical skills include Windows 10 operating platform; ability to research policy information from one proprietary mainframe and system and enter the data into a second proprietary system. A basic operating understanding of Microsoft Office tools (Outlook, Excel, Access and Word) as these tools are used in our daily processes for email communication and tracking. This would not include creation of new spreadsheets or tracking forms as tools are pre-existing. The individual will need to update existing tracking documents to manager their assigned work as well as managing their calendar.
• Verbal and written communication skills, attention to detail, and interpersonal skills.
• Individual will need to accurately document data and follow established process procedures with a general understanding of where to locate all information necessary to complete the process.
• Must be able to multi-task and follow procedures.
• Ability to work both independently and as an engaged member of the team, and manage one’s time.
Education/Experience
• Previous experience with:
o Windows 10 operating system.
o Working knowledge of Microsoft Word (how to create a Word Document and attach it to an email).
o Basic understanding of a pre-existing Excel spreadsheet.
• computers and applications such as Microsoft Word and Excel. Please be specific about what knowledge is needed for Work and Excel
• Education/Experience: High school diploma or GED required.
• Minimum 2 years of office/business experience. Personal Lines Insurance knowledge plus.
Instead of juggling multiple patients and constant interruptions, you provide one-on-one care in the home, allowing you to focus fully on your patient and deliver care with confidence and consistency.
In this role, you'll support pediatric patients with skilled nursing needs while working closely with a registered nurse and clinical leadership.
LPNs who thrive here value meaningful patient relationships, clear direction, and the reassurance of knowing support is always available when needed.
If you're an LPN looking for a role that offers stability, support, and the ability to make a real difference in a child's life, this position was designed with you in mind.
Care Options for Kids Benefits Paid Time Off (PTO) and flexible schedule Medical, dental, and vision coverage 401(k) retirement plan Weekly pay and direct deposit 24/7 On-Call for support CEU credits Training opportunities Nurse Referral Bonus Support That Keeps You Safe and Confident Easy-to-use Employee Portal that puts you in control, request shifts that fit your schedule and preferences, earn Care Bucks rewards, and stay connected to the COFK community.
24/7 on-call clinical support whenever guidance is needed Clear plans of care with RN oversight PPE provided in every home, including masks, gloves, and hand sanitizer Care delivered in alignment with CDC safety guidelines A clinical team focused on nurse safety and success Requirements Valid New Jersey LPN License or Multistate License Physical from within three years PPD or Chest X-Ray Valid BLS CPR card (obtained in person not online) Valid driver's license G-tube, trach, vent experience or willing to train Care Options for Kids is an Equal Opportunity Employer.
We celebrate diversity and are committed to creating an inclusive environment for all employees.
APPNUNB RDNUNB Salary: $62400.00
- $72800.00 / year
We are living our Purpose - To Care Deeply about People, Helping them to Eat Well and Be Happy. This Purpose guides everything we do and is why we are in business. We are using our service priorities - Safety, Friendliness, Presentation, and Efficiency to help us make decisions at work every day and are critical to the success of our business goals.
Job Summary: To deliver a great customer experience while safely and efficiently unloading and processing the delivery in the Grocery Department; to maintain a neat, clean and visually appealing department and to perform other tasks as required in an efficient and safe manner, within policy.
Minimum Required Qualifications:
- Ability to proficiently read, write, speak, analyze, interpret, and understand the English language.
- Ability to perform basic math.
- Ability to stand/walk for the duration of a scheduled shift.
- Ability to stand, bend, twist, reach, push, pull and regularly lift 25 lbs., and occasionally lift 50 lbs.
- Ability to work with fresh, dried and/or processed products, spices and powdered substances without negative allergic consequences.
- Ability to tolerate dust and chemical agents during routine housekeeping duties.
- Ability to interact with Customers in a friendly and helpful way.
- Ability to work cooperatively with others.
- Ability to work all assigned work schedules and comply with all time and attendance policies.
Essential Job Functions:
- Follow approved procedures for receiving, code dating, preparing, storing, price marking, arranging, and restocking products to ensure quality, accuracy and product rotation and protection.
- Unload and secure received product in appropriate storage areas using power or hand jack, carts, U-boats or bossies as needed.
- Block and face all products in accordance to Company policy or as assigned. Ensure that featured sale merchandise is attractively signed to stimulate sales. Handle all product not worked to the shelf according to department standards.
- Utilize CGO to maintain and order merchandise to keep product in stock, including using handheld terminal.
- Maintain a clean, neat, organized and safe work environment.
- Maintain Department sanitation and QA standards, including sweeping, mopping, removing cardboard and refuse as needed.
- Operate a baler or compactor.
- Perform all duties in accordance with Local, State and Federal regulations as they pertain to the Night Crew operation.
- Perform all duties in accordance with Company rules, policies, safety requirements, and security standards and all Local, State and Federal health and civil code regulations.
- Regularly lift, pull, push and rotate merchandise that weights 25 lbs., and that occasionally weights up to 50 lbs.
- Unload trucks and transport merchandise to Grocery Department that weights 25 lbs., and that occasionally weights 50 lbs.
- Stand in designated work area for duration of scheduled shift, which may exceed 8 hours per day.
- Check prices and be knowledgeable about location of items in the store.
- Understand and adhere to Company shrink guidelines as relates to departmental operations.
- Follow Company procedure for reclamation, disposal of cardboard, and plastic.
- Maintain communication within the Department and Company.
- Assist Department Manager as needed.
- Dress and groom according to Company policy including uniform, name badge, and hat or hair restraint requirements.
- Perform duties in accordance with QA hand washing standards and use disposable gloves when handling food.
- Greet all Customers and provide them with prompt, courteous service and assistance.
- Observe all safety regulations when operating equipment.
- Handle damaged or return-to-stock products according to Company policy, with priority attention given to refrigerated, perishable items, and sell by date.
- Check refrigeration equipment for proper performance regularly; report any failure immediately (where applicable).
- Be knowledgeable in the various types of products carried in the store.
- Utilize and maintain equipment as required by department; report any equipment problems immediately.
- Complete all applicable department training programs.
- Perform all duties in accordance with all ShopRite Service Priorities (Safety, Friendliness, Presentation, and Efficiency).
- Maintain punctual and regular attendance.
- Work overtime as assigned.
- Work cooperatively with others.
- Must be 18 years or older to operate balers, hi-lo's, power jacks, and slicing machines.
- Perform other duties as assigned.
Important Disclaimer Notice: The above statements are only intended to represent the essential job functions and general nature of the work being performed and are not exhaustive of the tasks that an Associate may be required to perform. The employer reserves the right to revise this job description at any time and to require Associates to perform other tasks as circumstances or conditions of its business, competitive considerations, or the work environment change. This job description is not a guarantee of employment.
This individual contributor is responsible for investigating/settling more complex and higher exposure/high frequency claims while providing an exceptional level of customer service and maintaining a high-quality claim file. This position reports directly to the Builders Risk Specialty Claim Leader in Major Accounts and Specialty.
Responsibilities may include, but are not limited to:
- Confirm coverage of claims by reviewing policies and documents submitted in support of claims.
- Analyze coverage and communicate coverage positions under direction of manager and coverage unit.
- Conduct, coordinate, and direct investigation of builders risk claims.
- Direct and monitor assignments to experts and underlying defense counsel.
- Evaluate information on coverage and damage to determine the extent of the loss exposure.
- Promptly and appropriately develop the file to provide accurate and timely investigation and loss analysis.
- Set reserves within authority and/or makes recommendations to supervisor concerning reserve changes.
- Effectively evaluate contract language and identify coverage issues.
- Maintain an active file diary to more file toward resolution.
- Recognize and pursue recovery.
- Adhere to all statutory and regulatory fair claims practices.
- Recognize and identify potential fraudulent claims.
- Effectively control the use, work product and expenses of outside vendors.
- Develop and maintain strong business relationships with internal and external business partners/clients.
- Serve as a technical resource to lesser experienced adjusters on the team.
- Successfully contribute to the development and delivery of the team's goals, objectives and results.
- Bachelor's Degree preferred or equivalent experience.
- 10+ years of commercial property claims adjusting experience.
- Current adjuster licenses in one or more states preferred
- Should have high degree of specialized and technical competence in the handling of high exposure claims with emphasis on hands-on file management.
- Knowledge of commercial insurance contracts, investigation techniques, legal requirements, and insurance regulations a plus.
- Ability to work independently and assimilate learning materials on many different subjects from various sources.
- Authoritative knowledge of the company's coverage, products, services, and liabilities.
- Ability to make independent decisions using best practices for guidance.
- Jurisdictional claims handling experience.
- An aptitude for evaluating, analyzing, and interpreting information.
- Excellent verbal and written communication skills.
- Ability to work well in a team environment.
- Innovative thinker with ability to multi-task.
- Ability to deal with customers in a professional manner.
- Ability to self-motivate and self-start.
- Strong interpersonal, negotiation and customer service skills.
- Must be able to effectively work in a team environment.
The pay range for the role is $105,300 to $179,000. The specific offer will depend on an applicant's skills and other factors. This role may also be eligible to participate in a discretionary annual incentive program. Chubb offers a comprehensive benefits package.
About UsChubb is a world leader in insurance. With operations in 54 countries, Chubb provides commercial and personal property and casualty insurance, personal accident and supplemental health insurance, reinsurance, and life insurance to a diverse group of clients. The company is distinguished by its extensive product and service offerings, broad distribution capabilities, exceptional financial strength, underwriting excellence, superior claims handling expertise and local operations globally.
At Chubb, we are committed to equal employment opportunity and compliance with all laws and regulations pertaining to it. Our policy is to provide employment, training, compensation, promotion, and other conditions or opportunities of employment, without regard to race, color, religious creed, sex, gender, gender identity, gender expression, sexual orientation, marital status, national origin, ancestry, mental and physical disability, medical condition, genetic information, military and veteran status, age, and pregnancy or any other characteristic protected by law. Performance and qualifications are the only basis upon which we hire, assign, promote, compensate, develop and retain employees. Chubb prohibits all unlawful discrimination, harassment and retaliation against any individual who reports discrimination or harassment.
Job InfoJob Identification 27877
Job Schedule Full time
Regular or Temporary Regular
Job Category Claims Adjusting
Business Unit United States
Legal Employer ACE American Insurance Company
202A Hall's Mill Road, Whitehouse Station, NJ, 08889, US
Through our dedicated associates, Conduent delivers mission-critical services and solutions on behalf of Fortune 100 companies and over 500 governments - creating exceptional outcomes for our clients and the millions of people who count on them. You have an opportunity to personally thrive, make a difference and be part of a culture where individuality is noticed and valued every day.
Field Health Benefits Coordinator
Location: Hamilton, NJ
Full-time with Full Benefits
Pay is $20/hour, which may be below your state's minimum wage. Please take this into consideration when applying.
Are you seeking an opportunity to make a real impact on a company that appreciates ideas and new ways of thinking?
Position Purpose: Reports to the Outreach Supervisor and serves as a key liaison between the NJ FamilyCare program and the community. Delivers presentations to groups and individuals, providing clear and courteous information about program benefits, enrollment, and eligibility. Assists beneficiaries with application completion and eligibility determination.
Working for you
Enjoy a positive, employee-friendly culture while playing an important role in supporting our clients.
- $20.00 per hour pay rate (bi-weekly pay)
- Full-time schedule (40 hrs. a week)
- Perkspot- Employee discount program
- Career Growth Opportunities
- Full Benefit Options - From the start, our paid training program will teach you all the skills needed to allow you to become successful in your role. We also offer a full benefits package, so you’ll be able to thrive both personally and professionally.
About the Role
- Assists walk-in and telephone customers with completing new and renewal applications, HMO selection forms and answers questions about the program.
- Conducts presentations to educate consumers about NJFC and the benefits of managed care within an office and call center setting, at Community Based Organizations, community events and home visits with some evening and some weekend events.
- Respond to telephone inquiries and complaints in a call center environment using standard scripts and procedures.
- Enters eligibility information into a web-based computer system and references other NJ-specific databases as appropriate.
- Determine eligibility for NJ FamilyCare according to the NJ FamilyCare regulations/guidelines by reviewing documentation and following procedures; prepare correspondence for missing information as appropriate; make outbound calls to obtain, clarify, or validate information
- Participate in and contribute to the quality improvement process
- Participate in training sessions conducted in Hamilton and at the regional offices.
- Other duties as assigned.
Minimum Experience Requirements:
- Associate degree from an accredited college or university.
- Two (2) minimum experience in the healthcare field.
- Knowledge and operational experience in Medicaid and/or CHIP programs are a plus.
- General knowledge of public health, managed care, human services systems, and local and statewide political systems preferred.
- Experience working with people representing diverse backgrounds is preferred.
Required skills/abilities:
- Knowledge of Medicaid and managed care programs.
- Ability to solve problems through analysis and ongoing feedback.
- Ability to work with people of diverse backgrounds.
- Ability to handle multiple tasks and meet deadlines, flexibility under pressure.
- Ability to maintain strict confidentiality.
- Capable of working independently
- Excellent verbal, written, and interpersonal skills.
- Bilingual capabilities a plus
- Ability to interpret and apply program policies and procedures as appropriate.
- Ability to use basic arithmetic procedures to determine the household size and income, and program eligibility.
- Ability to apply logical reasoning to make timely, effective decisions.
Pay Transparency Laws in some locations require disclosure of compensation and/or benefits-related information. For this position, actual salaries will vary and may be above or below the range based on various factors including but not limited to location, experience, and performance. In addition to base pay, this position, based on business need, may be eligible for a bonus or incentive. In addition, Conduent provides a variety of benefits to employees including health insurance coverage, voluntary dental and vision programs, life and disability insurance, a retirement savings plan, paid holidays, and paid time off (PTO) or vacation and/or sick time. The estimated hourly rate for this role is $20.00/h
Conduent is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, creed, religion, ancestry, national origin, age, gender identity, gender expression, sex/gender, marital status, sexual orientation, physical or mental disability, medical condition, use of a guide dog or service animal, military/veteran status, citizenship status, basis of genetic information, or any other group protected by law.
For US applicants: People with disabilities who need a reasonable accommodation to apply for or compete for employment with Conduent may request such accommodation(s) by submitting their request through this form that must be downloaded: click here to access or download the form. Complete the form and then email it as an attachment to You may also click here to access Conduent's ADAAA Accommodation Policy.
The CNC Machinist will operate conventional, special purpose, and computer numerical control (CNC) machines to produce precision machined parts used in assembly of power supply units according to department standards and procedures. Given the complex nature of the products, there will be significant hands-on training and interaction with various Magna-Power teams.
The CNC Machinist is responsible for:
- Fixturing, setting up, and operating production machinery in accordance with blueprints and specifications
- Programming, editing, and monitoring feeds and speeds of machines during the machining process to ensure operational efficiency
- Producing the required quantity of parts within established specifications and tolerances using machine tools such as lathes, milling machines, Bridgeports, bedmills, and EDM, etc.
- Operating metalworking, sawing, brazing, welding, and cutting equipment as needed
- Measuring finished parts with precision measurement tools, ensuring compliance with function, quality, and cosmetic specifications
The education and experience for this position includes:
- High school diploma or GED
- Minimum 1-3 years experience with Mazak CNC machines
- Experience programming and operating Fanuc EDM, Mazak Lathe, and Mazak milling machines
- Knowledge of fundamental concepts, practices and procedures, and experience operating CNC machines
- Good mechanical aptitude and math skills including arithmetic, algebra, and trigonometry preferred
- Knowledge of blueprint reading and tolerance specifications
- Experience with Fusion 360 or Inventor a plus
- Knowledge and understanding of BOMs, and other related manufacturing documents is preferred
- MIG Welding experience is a plus
In addition to competitive compensation, Magna-Power offers a comprehensive benefits package, which includes:
- Health insurance
- Dental insurance
- Vision insurance
- Life insurance
- Supplemental insurance
- 401k plan with company match
- Accrued paid time off
- Paid sick-time leave
- Tuition reimbursement
Excellent growth opportunities are available for individuals who are willing to learn and develop. Magna-Power Electronics values diversity in the workplace. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Should you require accommodations due to a disability at any time during the hiring and/or assessment process, we will make all reasonable efforts to accommodate your request.
General Description:
Supervises staff and executes QC Biochemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, processes and procedures. Establishes and implements QC Biochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the Biochemistry laboratory.
Essential Functions of the job:
- Lead the QC Biochemistry GMP laboratory through late phase activities.
- Oversee QC Biochemistry laboratory related quality systems to ensure conformance with regulations and quality standards.
- Supervise a highly efficient QC Biochemistry team. Identify and develop key talents.
- Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and, scheduling, etc.
- Execute laboratory bench work for analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as required.
- Ensure Biochemistry laboratory compliance with Environmental Health and Safety (EHS) standards.
- Ensure timely completion of testing (e.g., in-process, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results In support of manufacturing operations.
- Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures.
- Implementation of effective corrective actions and preventive actions (CAPAs).
- Participate in internal and external GMP audits where possible.
- Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports.
- Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.
- Manage, motivate, coach and mentor direct reports.
- Undertake any other duties as required.
Core Competencies, Knowledge, and Skill Requirements:
- Scientific degree (ideally in Biochemistry, molecular biology, biotechnology or related).
- Minimum of 5-7 years working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required.
- Working knowledge and experience with Biochemistry analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as well as instruments such Incubators, Biosafety Cabinets, Plate Washers, and Microplate Readers, etc.
- Knowledgeable with USP/EP and cGMP/EU GMP regulations.
- Direct experience in a GMP quality control lab is a must.
- Familiar with instrument and equipment validation.
- Expert knowledge of quality control principles, practices, and standards for the biopharmaceutical industry.
- Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
- Credible and confident communicator (written and verbal) at all levels.
- Strong analytical and problem-solving ability.
- Excellent project management skills.
- Hands-on approach, with a ‘can do’ attitude.
- Ability to prioritize, demonstrating good time management skills.
- Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
- Self-motivated, with the ability to work proactively using own initiative.
- Committed to learning and development.
Supervisory Responsibilities:
- Supervise a highly efficient QC Biochemistry team. Identify and develop key talents.
- Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and scheduling, etc.
- Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports.
- Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.
- Manage, motivate, coach and mentor direct reports.