Supervisor, Manufacturing Operations (ILP) 1st Shift
About The Position
Our Supervisor, Manufacturing Operations (ILP) plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, you will be responsible for daily coordination and working schedules of people and equipment in Inspection, Labeling and Packaging Operations and Label Printing Operations (as applicable). Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US. This is a full-time role for our 1st shift, working Monday through Friday from 6:00 AM - 2:30 PM. This is a set, consistent schedule based on site in our Sugar Land, TX location. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws.
Requirements
- High school Diploma or GED from recognized institution or organization required
- 2-3 years prior experience in cGMP / FDA regulated industry
- 1 year of supervisory or management experience required
- Well versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP's and have demonstrated strength in problem solving and resolution
- Will be required to undergo a color perception exam and must be able to produce a passing test result
- Will be required to undergo a vision exam and must be able to produce 20/20 vision with or without correction
- Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation
- Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas
Nice To Haves
- Bachelor’s Degree in Life Science or other related field
- Strong technical writing and verbal/written communication ability, including presentation skills
- Understanding of process flows, gap assessments and analysis of data to drive improvement
Responsibilities
- Supervises staff in execution of daily work; assures production technicians comply with standard operating procedures, cGMP regulations and safety requirements; provides constructive operator feedback
- Supervise label printing activities as needed
- Supervises ILP schedule in accordance with production schedule and customer demand
- Prepares and submits daily/weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities
- Establishes & maintains cooperative cross-functional relationships with peers in Quality, and other manufacturing operations colleagues to meet plant objectives
- Leads in development & maintenance of a safe manufacturing environment; Establishes methods in compliance with regulatory, plant, and corporate policies
- Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions
- Oversee production activities to assure performance to plan is achieved
- Recognizes and sets priorities and takes prompt action
- Forecasts and sets goals and objectives, identifies and allocates resources as needed
- Effectively identifies gaps in strategy and resources and resolves them
- Effectively arranges for work to be completed, schedules workflow and assignments to ensure delivery performance objectives for product or projects are met or exceeded
- Manages front line leadership in completion of daily operational tasks and assignments
- Counsels, trains, & develops front line leaders for efficient performance and assists in their career development; creates an atmosphere of team effort & open communication
- Supports regulatory inspections such as DEA and FDA audits
- Drives Quality Management System assignments (CAPA, Deviation, Change Control, GMP tasks) to on-time closure
- Reviews documentation such as batch records and logs to assure accurate recording of processes in conformance to policies and procedures and in compliance with Good Documentation Practices
- Develops training programs & assures training is conducted
- Reports & initiates production schedule changes, requests equipment and facility repairs, or modifications
Benefits
- Comprehensive health and wellness benefits including medical, dental and vision
- 401k retirement program with company match
- 22 paid days off plus 8 paid holidays per year
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
High school or GED
