Manager - cGMP Sterile Human Drug Manufacturing QC Laboratory
Manager - cGMP Sterile Human Drug Manufacturing QC Laboratory
Physical Location: Wichita, KS
Company:
JCB Laboratories, headquartered in Wichita, KS, is a leading manufacturer of specialty sterile human drug products in North America. JCB offers a well-established network that reaches thousands of specialized ambulatory surgery centers, hospitals, and clinics.
In addition to being a leader in producing sterile products in the U.S., JCB is part of a global organization with affiliates in 20 countries and over 1900 employees. JCB offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a generous company matching contribution; medical and dental; health savings account (HSA); holiday/paid time off.
At JCB, our associates are the framework of who we are and how we succeed. We value their accomplishments and offer long-lasting opportunities for growth and success. JCB is a great place to work and we look forward to adding more outstanding members to our team.
Job Description: The Quality Control department is responsible for support of sterile manufacturing and external customers. The primary functions of the laboratory are incoming material, finished product and stability/beyond-use date testing, as well as environmental monitoring microbiological sample analyses and testing products for sterility and endotoxins. Laboratory testing encompasses assays performed on incoming materials and finished compounded product to determine product safety and quality.
Position Title: QC Lab Manager
Dept: Quality Control
Position
Summary: This position is responsible for activities relating to the daily function of the Quality Control laboratory and strategic planning for the laboratory and laboratory staff. This position will be expected to manage and perform routine chemical analysis on finished product, in-process, stability, and raw material samples. The individual is the subject matter expert on analytical and microbiological testing. The individual is involved in data review and interpretation, including protocols, investigations, and laboratory documentation. This position is responsible for the entire laboratory team, and is required to perform staff management duties such as reviews, disciplinary action, and ensure training is performed. The individual operates with very limited supervision and must be able to work both independently and on teams.
Essential Duties &
Responsibilities:
Routine chemical analysis in a cGMP pharmaceutical laboratory
Compendial (USP, EP etc.) testing as well as execution of methods developed in-house
Emphasis on wet chemistry techniques
Other projects and duties as required/assigned
Functions as a subject matter expert within the analytical and microbiology laboratory
Monitors laboratory resources, identifies/reports resource gaps, and assists in recruiting, screening, procuring, and/or qualifying needed resources.
Writes, revises, reviews, and implements technical documentation including SOPs, protocols, reports, investigations, reference standard qualification reports, analytical test procedures, and change controls.
Determines root causes of out of specification and/or aberrant results and recommends corrective action. Ensures timely closure of investigations.
Performs training and supervises staff in use of instrumentation and testing techniques, protocols, procedures, cGMPs, and regulated safety guidelines.
May perform external audits of vendors with respect to laboratory GMP's.
Position Requirements
Education Required:
B.S. in a scientific field, preferably chemistry, biology, microbiology
Experience Preferred:
Five or more years of professional experience, preferably managing a QC lab.
Specialized or Technical Knowledge Licenses, Certifications needed:
Experience in raw material and finished product analytical chemistry testing in a cGMP Quality Control laboratory in the pharmaceutical industry.
Experience with wet chemistry techniques.
Minimum 5 years' experience in cGMP pharmaceutical laboratories.
Company/Industry Related Knowledge:
Broad knowledge of scientific principles and methods, including wet chemistry, chromatographic analysis, analytical methods (i.e., HPLC, GC, UV), and microbiological testing. Good written and verbal communication skills; highly organized. PC literate and able to quickly learn new software operational requirements. Thorough understanding of cGMP, CFR 210/210, sterile human drug manufacturing.
Job-specific Competencies
Possesses strong documentation, organizational and communication skills.
Demonstrates ability to multi-task and excel in a highly timeline driven and dynamic fast-paced environment.
Executes assigned tasks accurately and within pre-established timelines.
Complies with company policies, procedures, rules and regulations.
Travel Requirements: Limited, site audits
Estimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
