Senior Specialist Quality Control Jobs

Computer literacy desired for recertification tracking and Lactec back-up requirements.

Minimum high school diploma and 3 years' experience in a quality, manufacturing and/or laboratory environment.

Responsible for quality inspections and the adjustment of Finished Goods and Intermediate batches during the manufacturing process.

Must review all adjustments to the final product with the Quality Specialist prior to can-out and shipment.

Make batch adjustments to production batches, as required by the Quality Specialist.

Perform Dirt Check Filtration process on Finished Goods as required by Customer

Time management skills to optimize the analysis process and perform multiple tasks at the same time.

General knowledge of Federal and State regulatory requirements in a GxP environment.

Lead analytical method development/optimization/qualification and stability study projects.

Operate, calibrate, troubleshoot and maintain analytical equipment. Assist in laboratory equipment qualifications (IQ, OQ, PQ, and MQ).

Familiar with current GLP/cGMP, FDA, ICH, USP, and ISO regulations and guidelines, laboratory documentation, safety, and environmental requirements.

Proficient in computer skills including Microsoft Office (Word, Excel, PowerPoint) and others as applicable.

Aides to ensure that the quality system requirements are maintained.

Ensure quality assurance assessments at established supplier and client sites are performed in compliance with Company requirements

Manage and support issues in relation to scan docs.

Computer software skills including Microsoft Office, Word, Excel, Access, and Oracle (ERP) system.

Knowledge in API, ISO, and ASTM standards preferred

Review Source Documents including material test records to ensure quality, completeness, and accuracy to engineering specifications.

Assist in the management of sub-tier suppliers

Recommend process adjustments based on quality control data, visual inspection, and experience.

Help to manage and train of other technicians working in the quality process.

HSD required. Bachelor's degree and/or 3 to 5 years of equivalent training and/or experience preferred.

Works with guidance (but not constant supervision) to develop appropriate plans or perform necessary actions based on recommendations and requirements.

Excellent written and verbal communication skills.

Sound knowledge of cGMPs or equivalent Regulations. A minimum of 1 year of experience working in a GMP environment is required.

Independently manage competing priorities with limited instruction.

Coach colleagues and help them develop expertise/skills in related functions.

Perform other duties as requested by managers to support QC activities.

BS Degree with at least 5 years of work experience in similar roles.

Hands-on industrial laboratory experience with analytical techniques such as HPLC, UPLC.

Conducts review of logbooks and may perform reviews as assigned by management

Excellent interpersonal, verbal and written communication skills with strong technical writing experience required and ability to work in a team environment.

Other related job duties as assigned.

Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 2 years’ experience in GMP environment.

Direct experience in cell handling and potency testing.

Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of core duties.

Communicate statuses and completion of tasks to management

Knowledge of regulatory requirements, including FDA regulations and Good Manufacturing Practices (GMP) is preferred.

Calibrate, verify, and maintain laboratory equipment and coordinate associated maintenance, repairs & qualifications

Excellent communication skills, both verbal and written

Able to manage time and resources effectively, prioritize tasks, and work well both independently and with others

Able to manage a workload, prioritize tasks, and meet deadline

At least one year of experience with colleague coaching and leadership through indirect or direct management positions.

Proven track record of strong communications, analytical, organizational, project management and planning skills.

Bachelor's Degree, or high school diploma with an additional 4 years of experience in lieu of Bachelor's Degree

Related professional certifications such as CAMS or CFE

Expanded knowledge of federal regulations (USA PATRIOT Act, Bank Secrecy Act, Federal Financial Institutions Examination Council etc.)

Excellent critical thinking, communication, interpersonal and organizational skills.

Submit statistical information to site management for weekly or monthly reporting purposes

Ability to communicate effectively with audiences that include but are not limited to management, coworkers, clients, vendors, contractors, and other stakeholders

Enforce and champion the requirements of the site quality program and other project quality and technical requirements

Review and become familiar with the project technical requirements such as the prime contract, applicable codes, standards, and specifications

Job related technical knowledge necessary to complete the job

Ability to learn and apply knowledge of applicable local, state/province, and federal/national statutes and guidelines

Vacation, sick time and holidays

Volunteer time to participate within your community

Paid sabbatical after 5 years; every 3 years thereafter

Generous paid time off, including:

Maintain compliance with applicable ICH, GMP and safety regulations. Notify management of unexpected results, procedural deviations and equipment problems.

Perform Raw material sampling, testing, record data as per GxP requirements.

Hands on experience with Change controls, Deviations and CAPA is required.

Bachelor’s degree in scientific discipline (Chemistry, Biochemistry, Biology) + At least 5 years of experience in GMP pharmaceutical environment.

Master’s degree in scientific discipline (Chemistry, Biochemistry, Biology) + At least 2 years of experience in GMP pharmaceutical environment.

Lead and support GMP compliances and general QMS activities.

Job Requirements; Knowledge, Skills, Abilities, and Accountability:

Bachelor’s degree; or combination of education and experience.

Minimum 5 years’ successful experience in college financial aid in post-secondary educational environment.

Wide knowledge of regulatory requirements (e.g., federal, state, etc.) related to Title IV student financial aid.

Basic knowledge of CampusVue database (preferred)

Vice President of Financial Aid

Report OOT/OOS results and other deviations to area management and help remediate issues

Knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections

Knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements

Typically requires 4+ years of experience in GMP pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience

Participate in executing and/or review of method validations, method transfers and/or equipment qualification/requalification

The ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects is essential

Perform data entry and analysis as required to maintain production logs or other data capture tools.

Document process deviations in EtQ system and report to the Quality Control Manager.

Must meet/comply with all safety requirements, attend required training and wear personal protective equipment where required.

Minimum of 2 years experience

Demonstrated written and oral communication skills

Experience in the beverage or food industry

Bachelor or Master degree in Comp. Science, Engineering or other relevant technical field, or equivalent combination of work experience and education

Solid knowledge of networking, routing, switching, firewalls, routers, etc.

Previous hands on experience in identifying product failure modes and conducting root cause analysis is required.

Previous experience of using scripting tools (e.g. pl, Python, etc.) for product quality data analysis is a plus.

Previous experience of participating in ISO audit is a plus.

Excellent verbal and written communications and people skills.

Required Skills, Knowledge & Abilities:

Essential Job Duties & Responsibilities:

Assist the Quality Control Manager with projects from time-to-time

Communicate loan detail findings and resolutions with the Underwriting Manager as quickly as possible

3 years compliance and/or underwriting experience in the retail mortgage lending industry

Strong working knowledge of federal, state, and regulatory rules, laws, regulations, underwriting guidelines and statutes relevant to the mortgage industry

Working knowledge and technical understanding of the manufacturing and testing of biologics or Cell and Gene therapy highly desired.

Paper batch records (drug substance or drug product) review and batch disposition experience is a plus.

EnsuresthatManufacturing F acilities andEquipment arecompliant withcGMP requirements:

Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:

Performs line clearances for all manufacturing runs in the Cleanroom. Must be willing to gown.

Verifies Leukopak Receipt. QA primary contact for verification of release of starting material performed by Supply and Logistics for GMP production

Project management experience although not required is beneficial to this position.

Ability to communicate information to customers and senior management.

Ability to effectively present information to top management, and public groups.

Knowledge of cGMP, cGLP and FDA regulations, as well as internal quality-related procedures.

Practical and theoretical knowledge of the basic principle of validation and its applications.

Excellent verbal, presentation, and written communication skills.

Maintains and enforces the Quality Control assurance guidelines approved by the Company.

Oversees the project acceptance process consisting of interiors, exteriors, landscape and all supporting infrastructure.

Completes various human resources, financial, administrative, and other reports and analysis, and performs other duties as assigned or as necessary.

Knowledge of Software Quality Assurance or Software Engineering Methodologies.

Reviewing and interpreting business requirements and design specifications and translating them into test procedures.

Good communication skills (interpersonal, listening, written and oral), be self-motivated, organized, thorough, and efficient.

Skill with application testing using SQL, PL SQL.

Skill with testing of applications designed in Java, and .NET.

Skill with developing Web application testing automation using Java and Selenium, or similar.