Quality Control Spec I Jobs

Maintain and develop the Quality Management according to IATF 16949.

Cooperation on implementation of specific customer requirements into our system and our processes.

At least 2 years’ experience in similar role

at least 2 years’ experience in similar role

8D-report preparation, root cause analyses, corrective actions definition, verification of corrective actions.

Key contact for the customer.

Expertise in data management, data analysis, reporting word processing, and project management skills.

Knowledge of healthcare quality improvement processes and performance measurement.

Strong working knowledge of Microsoft Excel, VISIO and MS Project.

Coordinates assigned quality and process improvement activities which may include accreditation support, process improvement projects and monitoring of performance guarantees.

Conducts quality control reviews and internal audits.

Summarizes findings and prepare reports on findings.

Hearing impairment requiring a hearing aid(s) is acceptable

Follow lab procedures and handle all blood testing in the processing lab and ensure correct and accurate documentation

Perform, record and report testing on aphaeresis products

Able to use the Sysmex for the testing of blood component products

Able to accurately sample aphaeresis products for BacT sampling and utilize BacT testing equipment.

Perform weighing, pH testing and concentration testing on platelets and blood components using the appropriate testing equipment.

0-1 years’ experience in Biotech/Pharma industry.

Experience with CGMP and aseptic technique preferred.

Excellent interpersonal skills and ability to communicate clearly, effectively, and professionally.

Sampling USP Purified Water and Pure Steam systems aseptically.

Perform the enumeration and identification of microorganisms isolated in the facility.

Perform microbial bioburden, TOC, Nitrates, and Endotoxin on USP Purified Water/ Pure Steam samples.

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

Support as required the Quality Management Review Process

Minimum required education and experience: Bachelor degree or equivalent with 3+ years of experience, Master degree with 0-2 years of experience

Ensure that all projects are in compliance with GLP, QSR (including Design Controls), ISO or other applicable requirements.

Participate in FDA inspections, ISO Certification and surveillance audits and customer audits.

A minimum of 0 – 3 years’ experience in a medical device, pharmaceuticals, Quality/Regulatory Compliance, or other regulated product preferred environment.

Experience in a manufacturing environment.

Green Belt or Certified Quality Engineer Certification through ASQ

three to five years related experience in a Quality Engineering role

Assists with communicating broad quality engineering and related manufacturing principles and practices.

Reviews corrective action requests, inspection and audit results, failure reports, customer documentation, and other areas as required.

Interprets results of inspections, audits, and reports and implements solutions.

Experience using ISO 9001 quality management system auditing

Familiarity with quality management tools (control chart, FTA, FMEA, etc.) and MS Office (Word, Excel and PowerPoint).

Practical experience with materials analysis, testing, and chemical analysis equipment.

Extensive data analysis experience such as statistical process control of production data

Experience in defect reduction of high-volume manufacturing products

Conducting and implementing quality control systems for Li-ion battery manufacturing processes.

Equivalent military experience/training is acceptable.

2 or more years of electrical background test experience is acceptable.

Perform production line testing, troubleshooting and repair.

Visually inspect all units to be tested (pre-power inspection)

Duties require performing visual inspection on all product lines.

Duties require standard product testing.

o Assist with inventory management:

o Maintain all qualification and validation requirements for entering ISO classified area.

o Perform radiation safety duties according to SOFIE’s Corporate Radiation Compliance Program and site licensing requirements.

o Technical experience with computer-controlled automation preferred.

o Perform FDG and NaF synthesis according to SOFIE Standard Operating Procedures (SOPs):

o Ensure all materials/reagents are accepted according to SOPs and within expiry

Conduct all work in compliance with systems for maintaining a safe workplace (Management of Change, Environmental Management System, PSM etc.)

Familiarity with LIMS (Laboratory Information Management System) desired.

Knowledge / Skills / Competencies:

6 months to 2 years experience in a testing laboratory or equivalent with experience in a chemistry lab preferred.

Good math and analytical skills (ability to perform calculations).

Accurately and consistently perform routine testing in the QC lab.

{Has no supervisory responsibilities; manages own workload}

Completing supervisor assigned responsibilities to insure that departmental objectives are being met on time.

{Communicates moderately complex technical information within the team; Uses communication skills to exchange straight forward information}]

Good oral and written communication skills

Computer experience including Microsoft Office, Lotus Notes databases, and corporate ERP systems is helpful but not required

Education reimbursement: Financial aid to help propel your career to the next level

Support the Operations department in other non-laboratory functions, as determined by Operations management.

Perform other related duties as assigned by management.

Support and comply with the company’s Quality Management System policies and procedures.

Strong documentation skills in accordance with GMP requirements.

Evidence of strong analytical and problem-solving skills, and ability to make decisions with limited information and operate with autonomy.

Excellent oral and written communication and interpersonal skills.

Inventory management (tracking expiration/calibration due dates, restocking materials/equipment, proper disposal of expired materials, etc.)

Performance of qualification procedures for equipment and test materials, including microbiological media

Sterility, endotoxin, and bioburden testing of radiopharmaceutical APIs (active pharmaceutical ingredients)/products and components

Cleaning and disinfection of cleanrooms and related equipment on a routine basis using dedicated disinfectants and techniques per a written procedure

Routine review of and response to excursions for digital temperature and humidity datalogger data

Writing reports, investigations, instructions, and standard operating procedures

Bachelor’s degree, Engineering, Quality Management, or related field and/or equivalent combination of education and experience

Ensuring correct nonconform and suspected product management

Life insurance, short term disability, educational reimbursement, flex spending and employee stock purchase plan

Excellent PC skills with the ability to produce high quality document deliverables in short time scales

3+ weeks of paid time off plus 10 paid holidays

Medical/dental/vision for employee and dependents at a discounted rate

Assist with the improvement of quality compliance by recognizing continuing issues and bringing them to QA management’s attention

Ensures documents meet company standards and regulatory requirements

Minimum of 1 year of appropriate experience in GMP regulated environment.

Excellent written and oral communication skills.

Strong computer skills including Microsoft Word, Excel, and Access.

Medical, Dental, & Vision benefits – Effective Day 1

Knowledge of delivering educational programs to meet regulatory requirements and certification standards

Position specific testing requirement: N/A

Minimum Level of Education Required:

Minimum Level of Experience Required:

Prior job title or occupational experience:

Area of study or major: Graduate from an accredited school of nursing

Experience in leadership, project management, effective decision-making capabilities, strong analytical, problem solving and negotiation skills.

Demonstrates conceptual understanding and application of role-specific technical and Quality skills.

Effectively communicates (written and verbal) technical problems and solutions within small teams and to direct manager.

Improves manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.

Bachelor's Degree or Equivalent years of directly related experience (or high school+8yrs; Assoc.+4yrs).

0-1 years of relevant industry experience.

Ensure Quality Control Lab and equipment is kept in excellent working condition and meets/exceeds all safety requirements.

High School degree or an equivalent combination of training and work experience preferred.

Responsible for testing Barnhill-produced asphalt mix at any of company s asphalt plants in accordance with NCDOT specifications.

Oversee plant calibrations required by NCDOT specifications.

This job requires the following motions: standing, walking, stretching, bending, lifting, pulling, twisting, throwing, reaching and squatting.

Required regular lifting of 25 pounds and occasionally up to 50 pounds.

In depth knowledge of Laboratory Data Management System (LDMS) preferred

Effective time management and organizational skills needed

Perform water treatment duties as described by the Quality Manager where applicable

Perform Internal Clean in Place (CIP) setup as described by the Quality Manager where applicable

Effective attention to detail, analytical, multi-tasking, and problem-solving skills

Effective interpersonal, oral, and written communication skills

Support method qualification by creating QC test methods and performance of method qualifications

Review QC data generated from method qualifications, stability studies and GMP testing

Experience in Analytical Development or Quality Control roles supporting GMP testing/manufacturing of cell therapy, gene therapy or gene editing products

Experience or desire to learn HPLC/UPLC methodologies used in a GMP-laboratory.

Plan, coordinate and own preparation/aliquoting of custom critical reagents manufactured internally for use in GMP testing methods

Support logistical aspects of GMP stability programs for drug substances and drug product