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QC Raw Materials Manager

Company: GlaxoSmithKline
Location: Rockville
Posted on: May 15, 2022

Job Description:

Standort: USA - Maryland - RockvilleDatum: May 11 2022GSK currently has an opening for a QC Raw Materials Manager in Rockville, MD. The QC Raw Materials Manager is responsible for planning and prioritizing resource allocation in a Rockville Biopharma Quality Control laboratory to meet testing and release requirements of raw materials and oversee the operation of QC analysts. This role will be responsible for training, assisting in transferring assays from the development group, qualifying and validating new assays and implementing assays to be used for quality control purposes to support manufacturing and marketing of the product. The individual must have a thorough understanding of cGMP regulations and compendia requirements and demonstrate the ability to handle multiple priorities and interface with individual from various departments.Key Responsibilities:

  • Assures the laboratory programs/procedures are compliant with all regulations (domestic and international), cGMP's, cGLP's, and corporate requirements.
  • Assures all areas of responsibility are operated according to all safety regulations, procedures and expectations. - - - -
  • Assures all laboratory data are generated and approved under the current regulatory, GMP, and corporate guidelines. -
  • Reviews, evaluates, and manages initiatives to improve Quality Operations overall laboratory operational efficiency and GMP performance. -Encourages excellence and drives continuous improvement. - -
  • Responsible for the management and final approval of deviations, lab investigations, change controls, protocols. - -
  • Writes, updates, reviews and approves SOPs, Specifications, method protocols/reports. Manages analytical technical transfers, method validation, timelines and resourcing.
  • Establishes laboratory team objectives, testing priorities, and coordinates laboratory resources to align with objectives. Responsible for the control, testing and ultimate disposition of raw materials.
  • Assures laboratory personnel are qualified through proper training on appropriate departmental and site SOPs, training modules, GMPs, regulations, etc.
  • Participates in regulatory audits, agency inspections and the site internal auditing program. - -
  • Recruits, interviews, and hires laboratory personnel.
  • Conducts performance reviews, implements Employee Development Plans, and career pathing objectives with direct reports. - Provides developmental opportunities for laboratory personnel through training and project assignments. -The role requires office work, computer work, group meetings, laboratory work and thus requires sitting, standing, and walking. - It may involve working with analytical instruments and thus may involve exposure to chemical reagents that may be hazardous (corrosive, toxic, flammable, etc.)The role may involve occasionally working outside of 0800 - 1700 hours for on-call response to chambers or ADHOC Raw Materials testing.Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:
    • BS in Science field
    • 7+ years' experience in Quality Control in pharmaceutical biopharmaceutical industry
    • 2+ years of supervisory experiencePreferred Qualifications:If you have the following characteristics, it would be a plus:
      • Demonstrated supervisory and leadership skills.
      • Able to seek additional tasks or non-routine functions and accomplish them with minimal supervision.
      • Have knowledge of USP, EP, JP, ACC, BP, and ChP compendia methods performed in a cGMP environment.
      • Strong interpersonal and leadership skills. Solid team player able to function within team-based organisation.
      • Strong verbal and written communication skills.
      • Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including procurement, engineering, facility operations, validation, production and QA.
      • Able to prioritise and decide appropriate course of actions. - Effective at implementing decision.
      • Enthusiasm to identify and evaluate new assays and modern technology in improving proficiency in laboratory operations.
      • Have a continuous improvement mindset and drive performance and change.
      • Fully versed in GMP's, NIH, ICH Guidelines, FDA and other regulatory agency requirements for qualification/validation and testing of raw materials.Why GSK?At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is -ambitious for patients -- so we deliver what matters better and faster; -accountable for impact -- with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.*LI-GSK#globalsupplychain If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. -GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting site.

Keywords: GlaxoSmithKline, Rockville , QC Raw Materials Manager, Executive , Rockville, Maryland

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