QC Supervisor for 2nd Shift

Site Name: Guayama JV Posted Date: Nov 22 2021 In this role you will provide day-to-day supervision to laboratory staff. Plans, organizes and supervises the testing requirements of products, stability, validation samples, and the validation/calibration/preventive maintenance requirements of laboratory equipment. Ensures that work performed by the assigned staff complies with Corporate Quality Standards, Corporate Policies, Site procedures, and FDA and other government Regulatory Agencies This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Supervises assigned staff core techniques, routine and non-routine testing of samples, purified water monitoring, environmental monitoring, test method transfer/verification/validation, and validation/calibration/preventive maintenance of laboratory equipment. Serves as liaison between laboratory operations and equipment PM/calibration contractors. Monitors daily operations and provides direction as needed to maintain a safe and cGMP compliant work environment. Prioritizes staff work. Identifies training needs of assigned staff and ensures that those needs are satisfied. Ensures that safety requirements are met and followed by the staff. Serves as liaison between laboratory operations and external contract laboratories. Ensures that specification, analytical and microbiological methods exist for sample testing, reference standards and processes. Reviews laboratory data to ensure compliance with approved methodologies. Ensures that all equipment is calibrated, validated and properly maintained. Ensures adequate inventory of laboratory supplies is maintained. Provides input to inter-and intra-departmental groups regarding improved assays or equipment. Conducts or participates in laboratory investigations and supports the implementation of corrective actions and preventive actions as assigned in laboratory investigations. Initiates Investigations Reports (LIRs and MIRs) as needed. Acts as an information resource for support groups (QA, Technical Services, Engineering, etc.). The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product. Revises, reviews and approves procedures or specifications impacting on the identity, strength, quality, and purity of the products. Approves or rejects, starting materials, packaging materials, intermediates, bulk and finished products. Revises, reviews and approves change controls, procedures, protocols, reports, and deviation investigations as needed. Performs administrative task such as recruitment, hiring, retention, monitoring of attendance/vacation, performance evaluations and salary adjustment recommendations. Works with leadership to develop budgets. Fosters continuous improvement. Sets realistic objectives and clearly assign accountability and responsibility for tasks and decisions. Monitors and manages the efforts of subordinate colleagues to achieve short terms goals. Directs and implements creative/innovative ideas to improve workflow and promptness in the service that the department gives to others in order to obtain fast, complete, reliable and updated information. Takes measure to exclude from operations any person who might be a source of microbial contamination due to a health conditions following site procedures. Supervises overall sanitation practices and ensures personnel is trained in the sanitation procedures, which include washing hands thoroughly (and sanitizing if necessary, to protect against contamination with microorganisms) in an adequate hand-washing facility. Before starting work; and At any time when the hands may have become soiled or contaminated; Supervises and ensures personnel is trained in the processes to prevent contamination of components or products while performing testing to avoid potential growth of microorganisms and the potential for contamination. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: B.S. in Chemistry or Microbiology 5 + years of experience in a similar position within the Pharmaceutical Industry For Analytical Laboratories a Chemist License required Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. *This is a job description to aide in the job posting, but does not include all job evaluation details. 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/ Agencies GSK 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 For the Record site.