Job Title:      Supervisor, QC Labs

Location:      Columbus, Ohio

Job Type:     Full time

Req ID:          6503

 

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health.  Within Reach.  Every Day ®  for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

 

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Supervisor, QC Labs to join our team.  In this role, you will be responsible for leading, coaching, mentoring, developing and building a cohesive team of individual contributors. 

Provides leadership, mentoring and decision-making for laboratory investigations through driving investigations to root cause with associated documentation to support.

Supervises scientists and technicians in the performance of analytical testing.

You will work closely with QC, QAS, ARD, Manufacturing, EH&S.

 

Key Responsibilities:

 Regular onsite, predictable attendance. Mentors, leads, coaches, and develops employees; manages and addresses performance issues; and makes hiring, firing and compensation decisions to ensure individual and organizational performance currently and in the future. Communicates site and department goals and expectations to staff. Sets goals and expectations for staff with their input. Ensures conditions (time, equipment, etc.) necessary for staff performance are met and barriers to performance are removed. Measures direct reports' core job/MAG performance and contribution to team performance. Communicates site and department performance to staff. Provides direct reports with feedback on core job/MAG performance. Collaborates with direct reports to identify and enable their skill and knowledge development. Rewards and recognizes staff and team performance to build engagement. Ensures direct report positions are filled timely with the best qualified candidate(s).  Facilitate effective interpersonal relationships and performance across DRA, Change Control, and laboratory Flow Groups Assigns testing of samples Schedules laboratory activities and supervises laboratory work Trains new staff on laboratory safety and cGMP compliance. Approves and performs disposition of raw materials, components, intermediates, finished products and stability samples for release to production and analytical services as needed. Monitors workgroup/defined shift for efficiency, compliance to procedures and productivity Communicates with internal and external customers to ensure quality and timelines are met. Drives process improvements within QC Labs relating to work instructions, analytical procedures, specifications, and job profiles. Share scientific knowledge for the evaluation of compendial changes. Provide quality oversight of the sampling process for incoming materials (if applicable) Reviews and approves analytical work, laboratory investigations, and ensures implementation of CAPAs as needed Ensures laboratory operates in a safe and compliant manner Provides leadership across functional groups and drives support teams to affect improvements Drive consensus in teams toward solutions that are effective scientifically as well as from compliance and business perspectives involving change management, launch and various regulatory groups Drive cost-savings and ensure QLABS meets budget (as applicable) Other duties as assigned

 

Qualifications:

We value the skills and experiences candidates bring to the table.  While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

 

Minimum Education: 

Bachelor’s Degree in scientific discipline such as chemistry, pharmacy

              

Minimum Experience: 

Minimum of seven (7) years of GMP Quality pharmaceutical laboratory experience is required with some demonstrated project management or leadership skills and/or experience.  Must possess a specialized knowledge of ICH and FDA guidances, technical writing, laboratory investigation, and instrumentation with a GxP and regulatory emphasis.

 

Skills:

Capable of working independently and with minimal supervision and training Knowledge of Quality/GMP relevant regulations, ICH, and FDA guidances, method validation principles Thorough knowledge of cGMPs, cGLPs and laboratory operations Knowledge in chromatographic applications such as HPLC, GC, and UV-Vis, as well as dissolution, laser diffraction particle sizing, and titrations Proven competency with general analytical instrumentation, including the ability to assist direct reports in troubleshooting analytical methods Must be proficient in computer applications including Microsoft Word, Access, Excel, and LIMS.  Experience with SAP, LabWare, and Empower is preferred Must be able to prioritize multiple projects and assess contingency plans. Ability to plan short- and long-term capacity models to support commercial laboratory forecasting Must have proven analytical investigation skills, as well as good written and oral communication Demonstrated teaching and mentorship skills Ability to utilize active listening skills to understand the concerns or reasoning in order to be responsive, gain trust and build strategic relationships

 

What We Offer*:

Annual performance bonus, commission, and share potential. Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay.  Hikma will match 100% of the first 6% of eligible pay that you contribute. A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date).  Additional days granted upon reaching work milestone anniversaries. 3 personal days (prorated based on hire date) 11 company paid holidays. Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits. Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority. Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave

 

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment.  Benefits are subject to change as well as specific plan or program terms.

 

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

 

Agency Notice:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions.  In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.