Quality Control API Supervisor
Pfizer Inc.
Rocky Mount, NC
Job posting number: #7151848 (Ref:pf-4886522)
Posted: June 3, 2023
Application Deadline: Open Until Filled
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
You will be a member of Pfizer’s dedicated and highly effective Quality Control team. Under the general guidance and functional direction of the QC Laboratory Manager, the QC API Laboratory Supervisor is responsible for supervision of analysts performing physical and chemical testing in a safe, compliant, and efficient manner of commodities or raw materials. This position is specific to CQ API Laboratory. This position will evaluate analytical data to determine compliance with established specifications. The QC API Laboratory Supervisor is expected to resolve daily analytical and quality problems, generally without any additional high level technical assistance other than the chemical quality manager/director.
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
Consistently adheres to company, site, and laboratory safety rules and immediately raises any safety issues with supervision as soon as they are identified.
Follows procedures, adopting cGMP, cGDP practices.
Supervision of, physical and chemical testing and data review of commodities or raw materials.
Schedule work sequences for analysts and track progress of work sequences and provide feedback and coaching as required
Participate in daily and weekly planning discussions with team offering suggestions to improve efficiency and schedule adherence.
Responsible for writing lab investigations for lab errors made or procedural deviations found during lab operations. (RAACs or Event Records)
Evaluate analytical data to determine compliance with established specifications.
Resolve daily analytical and quality problems, generally without any additional high level technical assistance other than the chemical quality manager.
Review and provide feedback on SOP’s, Investigations, and Reports as needed in the absence of Management.
Spearhead special projects such as Continuous Improvement initiatives or process flow improvements
Act as Liaison between lab analyst, data review, and investigations were appropriate
Demonstrated strong technical and leadership skills
Ability to serve as primary CQ representative on multidisciplinary project teams
Act as Department representative for Internal and External Business tours and Audits
Qualifications
Must-Have
Applicant must have high school diploma (or equivalent) with eight years of relevant experience;
OR an Associate's degree with 6+ years of experience;
OR a Bachelor’s degree with at least 3+ years of experience;
OR a Master’s degree with more than 1+ year of experience.
Direct leadership experience
Prior experience in a Quality Control Laboratory environmentt
Knowledge of cGMPs and regulations outside of the US.
Good communication, organization and computer skills are required.
Knowledge of LIMS, Empower, and Microsoft Office programs is desired.
Ability to interface with multiple levels of people in the organization, including plant personnel and senior management.
Ability to drive teams and suppliers to complete commitments and projects in a timely manner. Strong and demonstrated leadership skills.
Prior experience with computerized laboratory systems (Lims, Empower and Sample Manager).
Must be familiar with operation and maintenance of routine Lab equipment.
Must be able to troubleshoot routine instrument and test method problems.
Strong written and verbal communication skills.
High level of organizational skills and independence.
Strong judgment and decision making ability.
Must be familiar with cGMP and cGLP for a pharmaceutical industry.
Nice-to-Have
Quality Control Laboratory experience
IMEX experience
Experience in a Quality Control or R&D laboratory and experience with a wide variety of analytical techniques (e.g., HPLC, GC, AA, UV-VIS, etc.) and biological techniques (e.g., BET, antibiotic potency, sterility, etc.) or incoming material commodities (glass vials, stoppers, plastic bottles, printed material, etc)
Technical writing experience
PHYSICAL/MENTAL REQUIREMENTS
Stand up for up to 8 hours, sit for up to 8 hours, walking, climbing stairs, responding to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective clothing (lab coat, safety glasses, gloves, face shield/goggles, apron), repetitive use of upper extremities.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
There are no out of the ordinary travel or shift requirements associated with the position. Individual will be expected to work nonstandard schedule as needed to support the business objectives.
Relocation support available: YES
Work Location Assignment: On Premise
Last date to apply: 6/15/2023
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.
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.