• Senior Associate , Quality Control Jobs in United States Of America - 25364525

  • Boehringer Ingelheim India Pvt Ltd
  • United States Of America, Usa
  • Save Job
  • 2 - 6 Years
  • Posted : above 1 month

Job Description:

Senior Associate, Quality Control - 1916512

Boehringer Ingelheim Fremont is the rapidly growing US arm of Boehringer Ingelheims Biologics Business Unit We are a fully integrated biologics operation with over 500 scientist and specialists, covering cutting edge early- to late stage CMC development, clinical and commercial drug substance and drug product manufacturing, medical device assembly for combination products and packaging operations

We are continuing our rapid growth, investing over $200m into the expansion of our capacity and capabilities, and creating approximately 200 new jobs

Driving this growth is an exciting pipeline of multiple Boehringer Ingelheim novel biologic entities (NBEs) and biosimilars, as well as, a growing diverse portfolio of therapeutics we develop and manufacture for other leading pharma and biotech companies This includes multiple commercial product launches planned over the next couple of years, for which we can tap into Boehringer Ingelheims unique experience of having brought 30 biologics to market globally

Leveraging our diverse talent pool, we are also driving technology and innovation globally, through major investment and collaborations into next generation manufacturing platforms and technologies, which may change how biologics will be made in the future

Whether we work on our own products, help partners to bring their products to market or innovate new technologies and approaches - Everything we do, we do to help patients! #LI-SS1 *I-SF1

Description

Responsible for providing analytical testing support by conducting cGMP assays for release, stability, validation, and in-process samples Responsibilities include conducting analytical testing per approved SOPs and methods, analyzing and reporting data, and maintaining lab equipment Report aberrant results to supervisor and assist in lab investigations as required Generate new and/or revise analytical SOPs and methods Maintain laboratory cleanliness and orderliness Perform all lab operations in a safe and compliant manner

Identifies problems and generates alternatives and recommendations to resolve problems Incumbent coordinates and conducts reviews and investigations in situations involving deviations of product quality from governing procedures, processes and regulations; assists with on-the-job training for junior-level staff and serves as a resource to them on technical or process questions

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies success We realize that our strength and competitive advantage lie with our people We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance Our competitive compensation and benefit programs reflect Boehringer Ingelheims high regard for our employees

Duties & Responsibilities

Analytical Testing
Under minimal supervision, performs testing, conducts lab investigations, problem-solves, provides supervision of product testing and reports aberrant results to management
Under minimal supervision, performs required cell and/or reagents qualifications
Performs Quality Control Biochemistry Testing Group (eg, HPLC, CE, PCR, Bioassay, ELISA, and Physico-Chemical)in a timely manner Follows well-defined and established procedures and best practices Reviews and approves QC test results in a timely manner
Documentation
Generates, reviews and/or maintains records or documents in a detailed and consistent manner
Ensure all equipment use logs are recorded for assays performed
Assists with QCs data management, including data review, assay monitoring (eg, invalid test log and control chart log)
Process improvement and compliance
Coordinates and manages continuous improvement projects
Revises standard operating procedures, training manuals, etc which are submitted to management for adjustments and final approval
Maintains specific QC files and database records for process and/or quality improvement efforts
Actively support cross functional teams and share information, as appropriate, with colleagues Effectively communicate with supervisors, colleagues and/or managers in other departments and sites Participate in method validation and method transfer activities
Demonstrate troubleshooting and critical thinking skills Highly productive, attention to detail, ability to manage own time and prioritize tasks independently to meet time lines Maintain laboratory cleanliness and orderliness Dispose expired chemicals timely, ensure all equipment is within calibration and/or qualification dates and resolve any malfunction issues through appropriate SOPs
Ensure that training is up-to-date and other personal development programs are in place

Requirements

Bachelors degree in Biochemistry, Chemistry or Biology is required
Demonstrates strong interpersonal and communication skills (both written and oral), a strong customer focus, and an ability to interact with various departments and levels
Demonstrates ability to work independently and as part of a team, to meet departmental/facility goals; is also able to work across functions to achieve common goals
Demonstrates strong attention to detail, and an ability to focus on details of execution
Demonstrates ability to work effectively on problems of a diverse scope and with analysis/evaluation of data
Demonstrates good facilitation, organizational and problem solving skills, as well as demonstrated technical expertise
Expertise is required in HPLC and CE The required expertise is with respect to demonstrating theoretical understanding and providing effective analytical troubleshooting
Five (5) years experience with cGMP is required Experience is required in conducting analytical investigations for Out of Specification or Out of Trend Results in accordance with regulatory guidelines Experience in trending analytical data (method data and product data) is preferred
Direct experience is required in method qualification, method transfer, and method validation in accordance with ICH guidelines
Direct experience is desired in participating and supporting regulatory inspections through explanations of methodologies, investigations, and/or laboratory systems
Experience in method development is desired
Knowledge of and the ability to implement CFR, USP, and ICH requirements is desired
Knowledge of LIMS, ELISA software (ie, Softmax Pro) and luminometer is required Ability to implement and demonstrate testing in accordance 21CFR11 is required

Eligibility Requirements

Must be legally authorized to work in the United States without restriction

Must be willing to take a drug test and post-offer physical (if required)

Must be 18 years of age or older

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 09th Jun 2020

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