The Quality Control department is responsible for support of the Manufacturing department and external customers. The primary functions of the laboratory are raw material, in-process, finished product and stability testing. Laboratory testing encompasses assays performed on raw materials and drug product at various stages to determine product safety and quality.
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. The individual is the subject matter expert on analytical testing. The individual is heavily involved in partner and regulatory audits, site metrics meetings, site-wide improvement projects, budgeting and 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.
Embraces a "team" working environment focused on achieving department goals by demonstrating willingness to accept assignments not specifically listed in the job description as allowed by the limitations of training, experience, and/or education.
Adheres to safety rules and awareness, demonstrates good safety practices at all times. Takes initiative to report and correct safety hazards. Uses Personal Protective Equipment (PPE) associated with assigned tasks.
Demonstrates and promotes the values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.
Executes against project plans and goals as assigned by Quality Management.
Meets productivity, quality and teamwork metrics for level. ?
Performs all assigned tasks according to applicable camps and internal written procedures.
Follows strict good documentation practices per company's SOP and cGMP regulation. ?
Actively completes assigned training activities and documents training within assigned time frames and before performing any activity associated with the training topic.
Functions as a subject matter expert within the analytical laboratory and provides support at all times.
Monitors laboratory resources, identifies/reports resource gaps, and assists in recruiting, screening, procuring, and/or qualifying needed resources.
Works independently and is able to facilitate non-routine assignments.
Mentors and develops staff to maximize staff performance and objectives.
Works in collaboration with other departments to evaluate and recommend improvements to analytical methods associated with validation, transfer, or review activities.
May manage inter-departmental projects to ensure timely completion of objectives.
Maintains utmost level of confidentiality at all times
Performs instrument/?method troubleshooting within analytical method parameters.
Writes, revises, reviews, and implements technical documentation including protocols, reports; reference standard qualification reports; analytical test procedures; and change controls. ?
May review analytical testing records/logbooks for compliance with cGMPs, compendial requirements, and Noven procedures/protocols.
Reviews and/or writes technical reports, procedures, investigations and protocols.
Provides problem solving skills to support the resolution and documentation of investigations for laboratory and manufacturing issues
Draws conclusions from data and communicates those conclusions is writing.
Determines root causes of non-conformance and recommends corrective action. Ensures timely closure of investigations.
Documents, develops and applies strategies to ensure achievement of scientific objectives by monitoring/ evaluating the completion of tasks.
Establishes policies, procedures, and practices associated with laboratory activities including safety, testing, scheduling and documentation.
Maintains and improves GMP compliance and documentation.
Schedules laboratory testing and associated activities to minimize operational disruptions to departments.
Performs training and supervises staff in use of instrumentation and testing techniques, protocols, procedures, cGMPs, and regulated safety guidelines.
Performs annual review of data generated by the Quality Control Laboratory. Generates data figures and trends. Presents and evaluates annual results to the Quality Management.
May perform internal audits of Quality Control.
May perform external audits of vendors with respect to laboratory GMP’s.
Assist with QC Director duties such as attending meetings in the absence of the Director
Determine and maintain laboratory budget.
Education / Experience:
Bachelor’s degree in chemistry. Seven or more years of professional experience. Broad knowledge of scientific principles and methods, wet chemistry, chromatographic analysis, analytical methods (i.e., HPLC, GC, UV), and an understanding of separation theories. Good written and verbal communication skills; highly organized. PC literate with basic knowledge of Microsoft office application software.
Employer will assist with relocation costs.
Internal Number: 0047
About Noven Pharmaceuticals
Noven Pharmaceuticals, Inc. is a dynamic specialty pharmaceutical company engaged in the research, development, manufacture, marketing and sale of prescription pharmaceutical products. We are committed to developing and offering pharmaceutical products that meaningfully benefit patients, with a commitment to advancing patient care through transdermal drug delivery.Over 325 Noven colleagues are working to advance our business and benefit patients at locations in Miami, FL and Jersey City, NJ. We are a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., the world’s largest manufacturer of transdermal patches, and we serve as Hisamitsu's platform for U.S. prescription pharmaceuticals, helping Hisamitsu bring the benefits of patch therapy to the world.Noven maintains state-of-the art, FDA-approved transdermal manufacturing facilities in Miami with capacity to produce several hundred million patches per year. These facilities are also approved by the U.S. DEA (Drug Enforcement Agency) for the production of controlled substances.Noven’s commercialized transdermal products include Minivelle® (estradiol transdermal system), the planet’s smallest estrogen patch; CombiPatch® (estr...adiol/norethindrone acetate transdermal system), the first approved combination (two-drug) patch; Daytrana® (methylphenidate transdermal system), the first and only patch approved for the treatment of ADHD. Noven's commercialized products are marketed through Noven Therapeutics, LLC. Noven's authorized generic division, Grove Pharmaceuticals, offers our products to the generic marketplace as Authorized Generics.Noven’s product development pipeline includes a range of prescription transdermal products that utilize Noven’s advanced transdermal delivery technology.