Address daily quality concerns and questions related to operating and environmental issues.
Clearly communicate complex issues to Management personnel.
Work closely with production personnel to complete in-process batch record review, resolve batch related issues, and complete timely final batch record approvals in order to meet release scheduling.
Complete gown qualification and maintains status for entry into Aseptic processing area. Must be able to demonstrate a sound knowledge of aseptic gowning practices.
Perform aseptic gown training and certification sampling.
Identify deviations and ensure the deviations are initiated by the appropriate personnel.
Perform and document assessments of aseptic behavior inside the aseptic manufacturing area. Must be able to provide real-time aseptic technique coaching and risk mitigation in the event of an aseptic technique violation.
Conduct viable and nonviable environmental monitoring throughout facility, including aseptic processing areas and classified manufacturing areas.
Collect facility waters and submit for testing.
Requisition of materials, maintaining inventory, and receive and store prepared media.
Enumerate bacteria and report excursions, if required.
Perform additional duties and responsibilities as assigned.
Ensure processes and products are in compliance with all local, state, and federal rules and regulations.
Oversee that processes are in cGMP compliance and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality.
Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.
WHAT YOU’LL BRING
Bachelor’s degree in science, engineering field, or equivalent experience.
Minimum one (1) year experience in the pharmaceutical industry (cGMP environment) and aseptic technique
Ability to get gown certified within 30 days
Physical requirements include standing and walking up to 8 hours (4 hours at a time for aseptic processing area), lifting or moving up to 35 pounds and reaching with hands and arms up to 6 hours. Must be able to climb or balance, stoop, kneel, crouch, or crawl up to 1 hour.
Good communication (oral, written) and interpersonal skills are necessary.
An acceptable visual acuity test is required for this position.
In addition to the minimum qualifications, the employee will demonstrate:
Embrace Indivior core culture principles.
Embrace the dynamics of team support, team collaboration and team success.
Celebrate the core wins of the organization and empower others to sustain a quality mindset.
Always have patient safety at the forefront in the efforts to provide safe and effective products to enhance and improve lives.
Celebrate and embrace diversity, equity and inclusion.
Proficient knowledge of manufacturing processes and standard operating procedures.
HOW WE INVEST IN OUR PEOPLE
Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:
Pursuant to various state Fair Pay Acts, below is a summary of compensation elements for this role at the company. The following benefits are provided by Indivior, subject to eligibility requirements.
Starting Salary: $64,800-$81,500 USD
Note actual salary is based on qualifications and experience
Competitive PTO plus company closure from December 24th- January 1st
Eligible to participate in Indivior’s bonus program, based on company and individual performance
Eligible to receive a yearly grant as part of Indivior’s Long-Term Incentive Plan
401(k) and Profit-Sharing Plan- Company match
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
Wellness programs as well as other discounts and perks
OUR SHARED RESPONSIBILITY FOR ETHICAL CONDUCT
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 behavior.
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.
Manager Obligations
Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.
Model and reinforce a Speak Up culture on your team.
EQUAL EMPLOYMENT OPPORTUNITY
EOE/Minorities/Females/Vet/Disabled are encouraged to apply!
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.
Want to learn more? Connect with us at www.indivior.com or follow us at www.linkedin.com/company/Indivior.
