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Job Details
Position Summary
Under general direction of the Laboratory Manager, you will be primarily responsible for Quality Control testing in launching finished product, routine testing of finished product and compliance with cGMP’s. In addition, you will support the regulatory requirements of finished product, supplier management and investigation of product issues. Support Laboratory Manager in administrative duties as necessary. Acting as a delegate in Laboratory Managers absence. This job position is compliance critical and responsibilities include ensuring continual and proper compliance with all division, corporate, and government regulatory requirements. It is the associate’s responsibility to observe all safety rules. Any condition thought to be hazardous or unsafe should be reported to your supervisor immediately.
Primary Duties And Responsibilities
* Ensures compliance with cGMP's, Environmental, Health & Safety regulations.
* Executes all Quality Control activities to ensure timely & compliant launch of finished products.
* Executes all routine Quality Control testing to ensure timely & compliant release of finished products.
* Executes the finished product Exception Program.
* Supports regulatory requirements of finished products.
* Supports the timely receipt and release of finished products.
* Prepares and executes method development, validation plans and protocols for the laboratory.
* Supports the document control system & record retention.
* Ensures laboratory equipment is calibrated & properly maintained at all times.
* Executes and supports batch record reviews to ensure timely release of finished product according to schedule.
* Develops and implements Standard Operating Procedures.
* Promotes the maintenance of a safe, accident-free and healthy work environment.
* Performs related duties as assigned.
* Support Laboratory Manager in administrative duties as necessary.
Experience And Educational Requirements
BSc in a scientific discipline; minimum of two (2) years in a cGMP facility in a Quality Control role. Experience in HPLC (High Performance Liquid Chromatography) is required.
Minimum Skills, Knowledge And Ability Requirements
* Excellent oral and written communication skills.
* Ability to effectively participate in cross-functional problem-solving teams.
* Ability to read and understand the English language for the purpose of following instructions.
* Ability to develop and maintain cooperative working relationships with others.
* Ability to use good judgment in order to carry out detailed instructions.
* Ability to work independently.
* Excellent teamwork and interpersonal skills.
* Ability to handle a variety of tasks simultaneously.
* Good problem-solving skills to evaluate quality problems and apply knowledge to identify appropriate solutions.
* Attention to detail.
* Computer literate.
* Good knowledge of Quality Assurance, cGMP and GLP.
* Experience in using HPLC in a GMP environment.
What Cencora offers
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Affiliated Companies
Affiliated Companies: BluePoint Laboratories
Equal Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned. #J-18808-Ljbffr