QC Manager - Avella - Houston (Pharmaceutical)
About the Job
When it comes to providing new hope and a new path to wellness, specialty pharmacy companies like Avella fill a unique and important role. Avella, now part of the Optum and UnitedHealth Group family of businesses, is bringing breakthrough medications, innovative clinical pharmacy programs and technological tools to providers and their patients across the nation. We create a viable level of access to many of the newest, most advanced medications in addition to a suite of tools that include mobile apps, text messaging tools and smart pill bottles. Whether you bring a clinical or business background to our opportunities, you can be sure that you'll be making a meaningful contribution to important solutions and services. Find out more about how you can start doing your life's best work. (sm)
The Quality Control (QC) Manager will oversee, manage and ensure all day-to-day QC operations. Such daily oversight shall include, but not be limited to, management and scheduling of testing, sampling, routine team member tasks, environmental monitoring, equipment validation, etc. for both of the in-house laboratories (microbiology) and contract laboratories.
- Implement cGMP system(s) and ensure compliance with all procedures and policies.
- Write and revise applicable policies and procedures for departments as aligned with corporate policies and expectations
- Oversees the daily operations of the microbiology department
- Oversees QC equipment validation, maintenance and calibration and QC laboratory scheduling and maintenance
- Manages the EM program and corresponding personnel
- Manages the microbiology laboratory activities and personnel. Main team tasks include environmental testing, personnel testing, aseptic process simulation testing, endotoxin testing, and incubation
- Manage the review and approval of specifications and test methods
- Reviews and approves product testing for finished drug product and raw ingredients
- Evaluates and approves out-of-specification (OOS) investigations; trends the OOS’s. Provided tracking and trending data to Quality Assurance on a monthly basis
- Ensure the completion of all non-conformance, deviations and other quality related issues associated with laboratory investigations
- Ensure the laboratories are properly equipped to maintain a high performance level for reliable test results applicable with all GMP’s and GLP’s
- Ensure laboratory personnel meeting required training and/or certification(s)
- A BS degree in a related science field or equivalent years of work experience may be considered
- Minimum of 4 years’ quality control experience in pharmaceutical or medical device industry
- (Lean, Six Sigma, FDA, BOP, and USP experience desirable)
Minimum of 2 years’ management experience in a microbiology and/or chemistry lab
2 years’ experience working directly with Licensed Pharmacists specializing in GMP operations
- Knowledge of laws and regulations regarding the use of pharmaceuticals for human and/or animal use (FDA and State)
- Proficient in a cGMP environment
- Working knowledge of Quality Control and Assurance programs or systems
- Experience working with regulatory agencies
- Ability to work in a fast paced environment, where timelines and follow-thru are key, and ability to multi-task critical
- Must possess a professional appearance, with excellent verbal and written communication skills including presentation skills are required
- Excellent computer knowledge/competence in Microsoft Office with strong Excel and Word experience
- High initiative with demonstrated results achievement, orientation, and a team player
- Must be self-motivated, dependable, organized, and must complete task start to finish with minimum supervision
Physical Demands and Work Environment
The physical demands and work environment are characteristic of those found in a typical laboratory environment. Capable of wearing all protective lab attire required for long periods of time. Some travel is required. Reasonable accommodations may be made for individuals with disabilities to perform essential functions.
Careers with Optum. Here's the idea. We built an entire organization around one giant objective; make health care work better for everyone. So when it comes to how we use the world's large accumulation of health-related information, or guide health and lifestyle choices or manage pharmacy benefits for millions, our first goal is to leap beyond the status quo and uncover new ways to serve. Optum, part of the UnitedHealth Group family of businesses, brings together some of the greatest minds and most advanced ideas on where health care has to go in order to reach its fullest potential. For you, that means working on high performance teams against sophisticated challenges that matter. Optum, incredible ideas in one incredible company and a singular opportunity to do your life's best work.(sm)
Diversity creates a healthier atmosphere: UnitedHealth Group is an Equal Employment Opportunity/Affirmative Action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law.
UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.
Job Keywords: Lean, Six Sigma, FDA, BOP, USP, cGMP, GMP, GLP, Pharmaceuticals, OOS, QA, QC