Indivior
Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease.
Title:
QC Analyst - Raleigh, NC Reports To:
QC Analytical Manager Location:
Raleigh, NC Position Summary
The QC Analyst role is a key position within the QC team supporting the startup of the GMP manufacturing facility, through routine utility testing, wet chemistry methods and LIMS setup. This role will report to the QC Analytical Manager and will work in a collaborative team setting within the QC Department. Essential Functions
Support technology transfer to the manufacturing site by performing method verifications and transfers for the QC Laboratory. Perform and review instrument qualifications and ensure calibrations are completed. Perform plant utility testing including TOC, Conductivity and pH. Assist in setting up data for the implementation of LIMS for the QC department. Perform analyses and complete peer reviews. Assist in the shipping of samples off site to Contract Test Laboratories (CTL). Author, revise, and implement documentation such as standard operation procedures for the QC Laboratory. Support the evaluation of test methods and the adaptation of processes and techniques for commercial purposes. Keep accurate documentation as per current Good Manufacturing Practices (cGMP) and ALCOA principles. Identify and document deviations. Any other duties as determined by management to support the QC team. Minimum Qualifications
Bachelor’s Degree in a Scientific field from an accredited university required. Minimum one (1) year of experience in the pharmaceutical industry required. Experience with USP, CFR, ICH, and ISO regulations and guidelines as well as Quality by Design (QbD) principles is preferred. Hands-on experience of running KF, HIAC, pH meters, Polarimeter, FT-IR, and various other lab equipment is a plus. Experience in relevant laboratory, computer, and data analysis skills required. NMR experience is preferred but not required. Strong organizational abilities and problem-solving skills. Competencies/Conduct
Knowledge of quality system methodologies, such as Failure Mode Effect Analysis, Pareto Analysis and understand Six Sigma concept. Ability to handle a wide variety of tasks under critical time constraints. Ability to work independently and in a group setting, collaborative, self-motivated, proactive, and critical thinking. Ability, at agreed upon times, to work a varied schedule with some potential weekend, early morning, or late evening hours, if required. Benefits
3 weeks’ vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts Guiding Principles
Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. Compliance Obligations
Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. Employee Obligations
Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Risk IQ: Know what policies apply to your role and function and adhere to them. Speak Up: If you see something, say something. EOE Statement
EOE/Minorities/Females/Vet/Disabled
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QC Analyst - Raleigh, NC Reports To:
QC Analytical Manager Location:
Raleigh, NC Position Summary
The QC Analyst role is a key position within the QC team supporting the startup of the GMP manufacturing facility, through routine utility testing, wet chemistry methods and LIMS setup. This role will report to the QC Analytical Manager and will work in a collaborative team setting within the QC Department. Essential Functions
Support technology transfer to the manufacturing site by performing method verifications and transfers for the QC Laboratory. Perform and review instrument qualifications and ensure calibrations are completed. Perform plant utility testing including TOC, Conductivity and pH. Assist in setting up data for the implementation of LIMS for the QC department. Perform analyses and complete peer reviews. Assist in the shipping of samples off site to Contract Test Laboratories (CTL). Author, revise, and implement documentation such as standard operation procedures for the QC Laboratory. Support the evaluation of test methods and the adaptation of processes and techniques for commercial purposes. Keep accurate documentation as per current Good Manufacturing Practices (cGMP) and ALCOA principles. Identify and document deviations. Any other duties as determined by management to support the QC team. Minimum Qualifications
Bachelor’s Degree in a Scientific field from an accredited university required. Minimum one (1) year of experience in the pharmaceutical industry required. Experience with USP, CFR, ICH, and ISO regulations and guidelines as well as Quality by Design (QbD) principles is preferred. Hands-on experience of running KF, HIAC, pH meters, Polarimeter, FT-IR, and various other lab equipment is a plus. Experience in relevant laboratory, computer, and data analysis skills required. NMR experience is preferred but not required. Strong organizational abilities and problem-solving skills. Competencies/Conduct
Knowledge of quality system methodologies, such as Failure Mode Effect Analysis, Pareto Analysis and understand Six Sigma concept. Ability to handle a wide variety of tasks under critical time constraints. Ability to work independently and in a group setting, collaborative, self-motivated, proactive, and critical thinking. Ability, at agreed upon times, to work a varied schedule with some potential weekend, early morning, or late evening hours, if required. Benefits
3 weeks’ vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay U.S. Employee Stock Purchase Plan- 15% Discount Comprehensive Medical, Dental, Vision, Life and Disability coverage Health, Dependent Care and Limited Purpose Flex Spending and HSA options Adoption assistance Tuition reimbursement Concierge/personal assistance services Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage Gym, fitness facility and cell phone discounts Guiding Principles
Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance. Compliance Obligations
Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. Employee Obligations
Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure Risk IQ: Know what policies apply to your role and function and adhere to them. Speak Up: If you see something, say something. EOE Statement
EOE/Minorities/Females/Vet/Disabled
#J-18808-Ljbffr