Job Information
Merck Operational Compliance Lead Tech -USA - North Carolina - Durham (Old Oxford) in Durham, North Carolina
Job Description
Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.
Position Description
This is a 1st shift - Day position .
The Vaccine Manufacturing Facility Lead Technician is an excellent opportunity for highly motivated individuals with expertise working in aseptic production and manufacturing operations. The Lead Technician is a manager developmental role and will serve on the Operations leadership team. Key responsibilities of the Lead Technician include direct support of operations on the production floor, coordination across processing suites, real-time batch record review, execution of aseptic processing requirements as needed, adherence to Good Manufacturing Practices, and leading in a team environment to accomplish shift and departmental goals. The ideal candidate for this position has demonstrated the ability to manage their own work activities as well as activities of others, contributing toward the success of the team through the use of their decision-making and problem-solving skills and their knowledge of aseptic manufacturing.
Responsibilities include, but are not limited to :
Executes operational review and comment resolution of batch records to include binder assembly.
Reviews and completes documentation to support production activities, including batch record events and management of forms and labels on the shop floor.
Assist with label preparation (e.g., GLIMS, Release) for upcoming production.
Executes room incursion initiation and approvals.
Assists Manager in leading a team-based culture through continuous improvement activities.
Performs inventory control and cycle counts. Resolves and reports issues with product accountability and SAP system discrepancies.
Assists team in real-time batch record review and ensures timely closure of shopfloor order.
Demonstrates a strong problem-solving ability to troubleshoot and communicate appropriately and effectively.
Conforms to established safety procedures in accordance with OSHA and other regulatory agencies.
Identifies and addresses compliance, environmental, safety, and process deviations as required and escalates to appropriate personnel.
Responsible for co-ordination and support of the scheduling for weigh and dispense of raw materials.
Review/inspection/delivery and overall management of samples (raw materials and components).
Coordinate shipping documentation and sample preparation for domestic and international shipments to applicable health authorities and intra-site
Author and own execution of Operations protocols
Assist in the development of and ownership of Operations corrective actions.
Author and revise Standard Operating Procedures
Support of internal and external regulatory inspections, presenting on topics as needed.
Leads/Supports production and quality projects and process system improvements.
Works independently and is capable of balancing shifting priorities without introducing disruption to the organization. Capable of working through uncertainty with minimal levels of manager direction.
Education Minimum Requirement:
High School Diploma or equivalent is required for this position.
Minimum (2) years GMP manufacturing/processing experience
Required Experience and Skills:
Technical writing experience, i.e. investigations, change requests, standard operating procedures, batch records, protocols.
Must be able to work both independently and within multi-functional teams in a fast-paced environment.
Experience with pharmaceutical process systems including PAS-X, DeltaV, SAP, RtReports, GLIMS
Experience with sample management
Sterile manufacturing shop floor experience highly preferred.
Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry.
Must be willing and able to lift 50 lbs., bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator.
Must be willing to be vaccinated/blood tested for titer for products manufactured within the facility if needed.
Computer literacy (internet browsers, e-mail, spreadsheets, word processing)
Experience with batch record execution, including good documentation practices.
Preferred Experience and Skills:
Bachelor’s degree in Life Science or Engineering
Associate’s degree in Life Science or Engineering
BioWorks Certificate (working in an FDA regulated industry)
Environmental Monitoring and Sampling
Proficiency in the use of SAP in a manufacturing setting
Review of Electronic Batch Record
Certified Yellow Belt/Green Belt
#MSJR
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Residents of Colorado
Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range. VETJOBS #EBRG
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/2/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/02/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R313239