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Senior Associate, Quality Control - Microbiology - Shift B

Company

Pfizer
Address , Sanford
Employment type FULL_TIME
Salary
Expires 2023-09-11
Posted at 9 months ago
Job Description
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
The Quality Control Microbiology department is seeking a highly motivated candidate to support GMP microbial testing at the Sanford North site for Shift B. The work includes testing of various microbial assays such as Environmental Monitoring (EM), Utility Monitoring (UM), Gas Testing, Sterility Testing, Bioburden testing, Endotoxin Testing, Growth Promotion, Micro ID, Data Review and other assays as needed for in-process, release, stability, etc. Focus areas to also include execution of analytical method qualification/validation protocols.
The candidate will be expected to support the Microbiology Laboratory such as authoring procedures, documents, stocking materials, inventory and other activities as necessary.
The successful candidate will be team oriented, have a “right the first time” attitude, detailed oriented, exhibit equity and inclusiveness and take initiative to learn and develop in the role to support the Microbiology Laboratory.
You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for analyzing microbiological products to support our quality programs. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to patients.
Your understanding of Quality Control instruments will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of methodology from R&D.
As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
  • Support detailing requirements for Laboratory Information Management System builds, building, testing and managing its Master Data changes.
  • Act as a QC Microbiology SME (Subject Matter Expert) during internal/external audits, risk assessments, and investigations
  • Perform tasks associated with maintaining Current Good Manufacturing Practices {part of GxP} compliant Quality Control and Stability laboratories.
  • Perform assay qualifications for in-process, drug substance, buffers, etc. and author reports
  • Interact closely with other departments to ensure efficient, compliant and timely execution of product activities
  • Ability to author environmental monitoring excursion reports, deviations, CAPA and SOPs as needed
  • Demonstrated understanding of USP, EP and FDA microbiological testing requirements
  • Perform analysis and data analysis of in-process, APIs, and stability samples using existing methods
  • Perform testing including, but not limited to clinical and/or commercial product, raw materials, validation, stability, and Environment Monitoring samples.
  • Perform instrument performance qualifications
  • Lead efforts to improve process performance, procedures and reporting to meet changing quality and regulatory compliance.
  • Able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records.
  • Utilize laboratory instruments and equipment in accordance to established procedures to include but not limited to air samplers, particle counters, endotoxin readers, microscopes, etc.
  • Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects
  • Author and review Quality Control SOPs
  • Perform bioburden, endotoxin, sterility testing, Micro ID, TOC and Conductivity
  • Assist in investigation and review of GMP quality events to include deviations, out of specification reports and audit findings
  • Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
  • Support preparation of media, receipt, storage and handling of Bio ball cultures, and investigations related to microbiology.
  • Participate in out-of-specification and failure investigations and recommend corrective actions and demonstrate problem solving abilities.
  • Maintain QC lab and provide assistance as needed during equipment and facility activities
  • Operate under minimum supervisor and support special projects as needed
  • Support Microbiological staff members as needed
  • Assist in trending and EM data and generate quarterly and yearly reports
  • Review and authorize all laboratory data and have an extensive overall knowledge of all laboratory operations.
  • Author standard operating procedures, assay qualifications and other GMP documents as necessary
  • Operate in high regard, integrity and efficiency to generate accurate and quality results with a customer focused mind-set
  • Train junior colleagues and may develop training plans and/or oversee training activities for groups.
  • Initiate and participate in EM excursion investigations and assess any potential impact on product quality
  • Train and mentor other associates on lab assays
  • Perform safety inspection of laboratories and surrounding office area as assigned and prepare a report.
  • Perform routine and non-routine environmental monitoring (total particulates, air viable and surface viables), utility monitoring and gas testing of GMP manufacturing clean rooms and lab areas
  • Support continuous improvement projects related to QC
  • Aid as necessary to maintain the function of the QC lab to include ordering materials, inventory, general housekeeping and other duties as necessary
Role Responsibilities
  • Good decision making based on procedures, experience and guidance.
  • Abide by Pfizer’s quality standards set by regulations, policies and procedures.
  • Ability to gown for and work in a cleanroom environment
  • Work to the highest degree of ethical and moral standards.
  • Be able to communicate effectively with colleagues and supervisors.
Qualifications
Must-Have
  • Experience and knowledge of GMP, following standard test methods.
  • High School Diploma (or Equivalent) and 8 years of relevant experience OR an Associate's degree in Life Sciences with 6 years of experience OR a Bachelor's degree in Life Sciences with at least 3 years of experience OR Master's degree in Life Sciences with more than 1 year of experience.
  • Excellent effective written and verbal communication and interpersonal skills
  • Understanding of pharmaceutical manufacturing, packaging, and quality assurance operations
  • Detail oriented with Quality systems knowledge
  • Knowledge of research unit clinical and analytical Laboratory environment
  • Experience in environmental monitoring in a GMP environment, GMP microbiology laboratory, assays such as bioburden, endotoxin, TOC, conductivity, plate reading, gram staining, Micro ID, sterility.
  • Knowledge of Microsoft Office applications e.g. Word, Excel, Power Point, MS Visio, etc.
  • Experience in microbiological testing of water
  • Ability to work in a team environment
Nice-to-Have
  • Knowledge of computer system hardware, infrastructure and networks
  • Relevant pharmaceutical experience

Physical / Mental requirements
  • Ability to see near and far, color, peripheral vision, depth and the ability to focus
  • Ability to successfully gown in a GMP clean room environment without compromising the integrity of the gown.
  • Frequently lift and/or move objects up to 30 pounds
  • Ability to crawl, crouch, kneel, stoop, balance and climb
  • Use of arms, fingers and hands to feel and reach
  • Walk/stand during entire length of shift
  • Able to stand 1-2 hours at a time, sit for 2-3 hours at a time
Non-Standard work schedule, travel or environment requirements
  • 4 days (Wed-Sat) on B Shift 10 hours/day schedule ( 6:30am-5pm )
  • Occasional off shift days/hours and holiday worktime may be required as necessary.
Other job details
  • Last day to apply: August 24th, 2023
  • Employee Referral Bonus
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Quality Assurance and Control
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