Covetrus · 2 hours ago
Laboratory Production Manager
Covetrus is a company focused on laboratory services, and they are seeking a Laboratory Production Manager to oversee laboratory staff and day-to-day activities. The role includes managing operations, ensuring compliance with quality standards, and developing policies to enhance laboratory performance and safety.
Responsibilities
Manages and is responsible for the day-to-day operations and success of the QC Laboratory including sample processing/intake, microbiology, and chemistry sections
Conducts candidate screening, interviewing, hiring and onboarding of new personnel and helps identify where FTE is needed for the success of the laboratory, conducts terminations of employees as needed
Monitors employee performance for day-to-day activities and performance goals. Oversees supervisors/leads and provides guidance, coaching, and training for their development and progression and performs performance evaluations, mentoring and development of skills of Laboratory Personnel
Develops and supervises staff through provision of timely feedback and use of appropriate Human Resource policies and tools to facilitate and ensure the ability of staff to achieve highest level of professional growth and desired performance standards
Serves as a point of escalation for issues requiring discretion to resolve – both personnel and laboratory related
Monitors productivity reports and time management reports to ensure laboratory is meeting benchmark metrics (KPIs and OKRs)
Maintains oversight of testing volume to ensure service standards are met and maintained, including lab sample turnaround time which includes 3rd party testing
Strong knowledge of maintenance, calibration, and function of HPLC-DAD, LC-MS, and TOC instrumentation
Identifies problems (both personnel and technical) that may adversely affect test performance or reporting of test results, and determines solutions
Partners with production to anticipate workloads and overall efficiencies of the laboratory and represents Laboratory Services in cross-functional meetings and projects
Implements programs, processes, and operational improvements to enhance the level of internal and external customer service provided
Collaborate with Quality Assurance to help coordinate training and oversees/conducts training for specified topics related to laboratory functions
Assist in the development and maintain compliance of SOPs, forms, and other laboratory documentation, policies, and procedures as well as instrument calibration and maintenance
Participates in conjunction with laboratory Leads/Supervisors, Quality Assurance and the Laboratory Director in implementation of GLP-FDA, USP, ICH and ISO regulations and guidelines to ensure laboratory is compliant and current
Coordinates with QA for external audit readiness with regular reviews of personnel training, records, and other documentation that may be reasonably expected to be requested during an audit
Assists Quality Assurance in the execution of Internal and External Audits, plans and executes responses to bring any out of compliance findings into compliance
Ensures adherence to departmental operations and capital budgets, may assist in operational decisions, departmental budget development, reconciliation, and capital expenditure tracking
Coordinates with Technical Manager for the use of laboratory personnel and equipment for the execution of special projects and testing that falls outside the regular scope of QC testing and procedures
Assists Technical Manager for the transfer of methods, techniques, and instrumentation between teams
Assists Technical Manager and Quality Assurance with technical trainings and assessments between associated laboratory teams
Generate and provide appropriate explanation and documentation of testing as appropriate to respond to external inquiries regarding testing methods, BUD determination etc
May participate in qualification of suppliers in accordance with guidance documents
Helps to select and negotiate terms of contract with outside vendors, purchase of equipment and contracts for services provided at 3rd party contract laboratories, acts as point of contact for maintenance contracts and other supply vendors
Maintains equipment maintenance and calibration either internal or 3rd party
Responsible for organization of laboratory space, inventory, and personnel
Performs and updates cost-per-test analysis that informs test charges for new and existing tests
Provides financial analysis of send-out costs vs. in-house costs for specific tests and advises upper management team of opportunities for in-sourcing of laboratory tests and services, identifies opportunities to bring testing in-house
Assists in evaluation of new instrumentation and/or methods as required in order to improve laboratory testing performance and may oversee the troubleshooting/problem solving of instruments and methods
Aid in the development, implementation, and communication of departmental mission, vision, and strategic plan
Establishes and tracks departmental goals in conjunction with Quality Director, Quality Assurance, corporate goals, and vision
Qualification
Required
Bachelor's Degree in scientific discipline
10+ years of experience working in laboratory environment
Proficient ability in Word, Excel, Outlook, and PowerPoint
Proficient with using Quality tools such as FMEA, Fishbone, Process flow chart, 5 whys, Fault tree analysis, etc
Communicates in a professional manner with outside auditors, regulators, inspectors, and personnel from other departments internally
Demonstrated decision making ability with regard to both personnel and technical questions while maintaining regulatory appropriateness
Maintains a level demeanor in stressful situations and possesses skills to mitigate issues
Experienced with working in a laboratory or regulated environment and ability to comply with laboratory standards
Proficient with 21 CFR 58 and 211, ICH Q7, Q9, Q10, USP, GFI 256 Compounding Animal Drugs and Bulk Drug Substances, and ISO 17025 practices, policies, guidance's, and regulations
Advanced knowledge of maintenance, calibration, and use of HPLC-DAD, LC-MS, TOC, UV-VIS, water activity, dissolution, disintegration, and microbial testing
Advanced knowledge of scientific principles and concepts with strong mathematical and reasoning ability, with knowledge of pharmaceutical APIs and dosage forms
Advanced problem-solving skills and the ability to work collaboratively with other departments to resolve complex issues with innovative solutions
Possesses strong verbal and communication skills, attention to detail, time management skills, exceptional observation skills, organization, and thorough documentation
Demonstrates leadership skills including ability to effectively develop, assist, train, and coach laboratory personnel
Demonstrated knowledge in managing and improving laboratory operations, personnel safety, and quality
Demonstrated success in leading laboratory operations to achieve improved performance and profitability
Willingness to adapt to changing environment and support the current business needs
Preferred
MS Degree or higher in scientific discipline
Experience working in 503A testing laboratory, ISO accredited or FDA registered facility
Advanced knowledge of pharmaceutical testing applications for microbiological or chemical analysis of API through experience or education
Benefits
401k savings & company match
Paid time off
Paid holidays
Maternity leave
Parental leave
Military leave
Other leaves of absence
Health, dental, and vision benefits
Health savings accounts
Flexible spending accounts
Life & disability benefits
Identity theft protection
Pet insurance
Sales Positions are eligible for a Variable Incentive
Certain positions may include eligibility for a short term incentive plan
Company
Covetrus
Covetrus specializes in the production and distribution, inventory management, software and prescription management for veterinary care.
H1B Sponsorship
Covetrus has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (7)
2023 (4)
2022 (20)
2021 (3)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2022-05-25Acquired
2021-01-01Seed
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