Senior Quality Control Specialist Jobs

Knowledge of quality management systems, current Good Manufacturing Practices, expertise with QC principles and compliance requirements.

Work with management and quality assurance in on-time closures of Deviations and LIRs.

4+ years of QC experience in the pharmaceutical laboratory industry

Lead laboratory investigations for OOS, OOE, OOTs and system suitability failures.

Lead deviation investigations related to QC laboratory, excursions, and adverse trends.

Work with QC team for data gathering, observing processes for investigations, and performance of associate interview.

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.

Excellent interpersonal, verbal and written communication skills with strong technical writing experience.

Other related job duties as assigned.

Bachelor's degree in scientific disciplines such as Chemistry, Biochemistry, Biology, Microbiology or related field with 5 years’ experience in GMP environment.

Extensive knowledge of GLP and GDocP principles.

Capable of delivering to assigned work schedule with attention to detail and accuracy.

Support department risk assessments and participates in audit walk-throughs.

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.

Experience in creating clear and concise documents (PowerPoint, memos, etc.) for educational purposes and statewide distribution.

At least 2 years of related experience in a hospital, regional or central cancer registry.

Bachelor’s degree in a health-related field, or substitute with four additional years of related experience.

Must maintain CTR credentials by attending either in-person or virtual educational meetings or other methods as prescribed by the NCRA.

Excellent knowledge of medical terminology, medical procedures, anatomy and physiology, and the cancer disease process.

Strong communication skills. Must have the ability to communicate accurately, concisely, and clearly.

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

Experience in creating clear and concise documents (PowerPoint, memos, etc.) for educational purposes and statewide distribution.

At least 2 years of related experience in a hospital, regional or central cancer registry.

Bachelor’s degree in a health-related field, or substitute with four additional years of related experience.

Must maintain CTR credentials by attending either in-person or virtual educational meetings or other methods as prescribed by the NCRA.

Excellent knowledge of medical terminology, medical procedures, anatomy and physiology, and the cancer disease process.

Strong communication skills. Must have the ability to communicate accurately, concisely, and clearly.

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.

Skills / Knowledge - Acquires and applies job skills and learns company policies and procedures to complete assigned routine tasks.

Skills / Knowledge - Client polices, departmental procedures and applicable computer applications

What Are Our Desired Skills and Capabilities?

Must have 1-2 years of recent call center experience

This role has to the potential to be Work from Home after training is completed

Acts as a back-up to the customer service team as necessary to resolve customer account inquires during inbound customer service calls.

Experience with the technical transfer and qualification/validation of analytical assays.

$34.00 (entry-level qualifications) to $39.00 (highly experienced)

Lead the testing of assigned lot release and stability samples to meet expected turnaround time requirements.

Participate in method qualification, validation and transfer activities.

Support instrument installation and operational qualification activities (IOQ).

Ensure a compliant work space by adhering to and enforcing GxP requirements.

Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’)

OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)

Strong knowledge of cGMP in a pharmaceutical setting

Strong knowledge in analytical techniques in a QC/commercial setting (e.g. HPLC, dissolution, GC, KF, etc.), including method validation/transfer

Experience with both drug substance and drug product (oral solid dosage forms) testing

Effective communication skills, both verbal and written

Responsible for QC sample and retain management

Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) and lab management software system (LIMS)

Document and perform sample management related non-conformance investigations

A minimum of two (2) years related experience in medical device, biopharmaceutical, or pharmaceutical industry

Solid understanding of regulatory requirements, policies and guidelines

Experience with Quality Control document reviews and regulatory inspection processes

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