Overview
QC Technician 1st shift ( Monday thru Friday 3:00 pm to 11:30 pm) Jobs in Clinton, TN at Techmer PM, LLC
Job Description
The Quality Senior Specialist provides expertise pertaining to qualification/validation activities supporting a vaccine expansion facility at West Point, PA. The role will support various initiatives as the B63A Syringe Filling Facility capital project progresses through various stages including Process Qualification (PQ), Tech Transfer, Process Performance Qualification (PPQ), licensure into commercial manufacturing.
Primary Responsibilities:
The Quality Senior Specialist will be responsible for comprehensive management of all activities required to successfully support facility startup and routine manufacturing to include:
Assume project management opportunities, by leading and participating in process improvement, learning events, or business support initiatives, as guided or approved by Quality management.
Direct support of regulatory inspections and audits.
Direct support of validation activities, including review and approve qualification/validation documents for equipment and process.
Independently supports resolution of technical and operational problems through collaboration with peers.
Applies appropriate risk management while adhering to cGMP requirements.
Makes decisions guided by policies and procedures that impact the team’s ability to meet performance objectives.
Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes.
Participate in Quality Risk Management activities.
Review and approve technical protocols (ex. Development studies).
Provides input, direction, and approval of Quality Notifications (QNs) and Change Requests (CRs).
Author, review, and approve SOPs.
Develop batch disposition process for IPT.
Other duties as requested by Management.
Minimum Education Requirements and Experience:
Bachelor’s degree (BS) in a science or engineering discipline, or other relevant degree. A minimum of five (5) years’ experience supporting the pharmaceutical manufacturing industry, specifically in pharmaceutical Quality, Operations, Technical Operations and/or Validation.
Required Experience and Skills:
Ability to work independently and as a member of a team.
Previous experience with investigation and CAPA, Validation and Change Control processes.
Has in-depth knowledge of cGMPs including domestic and international regulatory requirements.
Expected to possess a high degree of problem-solving ability.
Must have demonstrated ability to independently manage multiple high level/ priority projects, ensuring timely completion.
Preferred Experience and Skills:
cGMP experience in a sterile, bulk or finished pharmaceutical environment.
Drug Substance, Drug Product or Raw Material / Component Release.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
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:
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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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, Monday – 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”.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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:
02/19/2025
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:R335665
Title: QC Technician 1st shift ( Monday thru Friday 3:00 pm to 11:30 pm)
Company: Techmer PM, LLC
Location: Clinton, TN
