Overview
Engineering and Quality Assurance Trainee Jobs in Rockford, IL at 425 Manufacturing, Inc.
Job Description
The Associate Director, Quality Assurance will be responsible maintain the clinical supply chain for sterile dosage drug product manufacturing at the Rahway, NJ site. This role will manage and execute GMP quality assurance activities directly related to internal and/or external sterile drug product production and batch release for clinical trial material supply. This role must assure that quality systems and controls for investigational new drugs (investigational medicinal products) meet all internal quality requirements, regulatory standards, and meet continuous clinical supply and delivery expectations.
Essential Duties and Responsibilities:
Act as Quality representative for internal or external manufacturing and testing of programs. Perform quality assurance activities for sterile drug product manufacturing in clinical development.
Ensure all drug products are manufactured in compliance with cGMP and regulatory filings. Ensure procedures are followed and specifications met to release or reject materials.
Review and approve batch production records, raw materials, intermediates, finished dosage forms; all related documentation, investigations, deviations, change records, etc. for each batch.
Review and approve quality investigations of events or non-conformances, complex and non-routine issues.
Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance, regulatory, etc. at all levels.
Establish, educate, and enforce standard operating procedures required under GMP.
Participate or lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions.
Maintain a state of readiness for and participate in audits and inspections.
Represent the department or area on project teams or committees establishing GMP, or quality standards, policies or expectations within our company
On-site support of facility & staff (minimum 60% on a weekly basis)
Education Minimum Requirement:
Bachelor’s degree in a science, engineering, or related discipline; an advanced degree or certification in a management, technical, quality, or regulatory discipline will be preferred.
Required Experience, Knowledge, and Skills:
Minimum of 10 years of experience in Pharmaceutical or Biotechnology industry role(s).
Strong compliance knowledge and understanding of health authority regulations, and interpretation and application of GMPs within an R&D environment (i.e., apply the GMP Continuum).
Direct experience in GMP quality, operations, or laboratories. GMP experience at the interface between quality and either an internal manufacturing or laboratory function or external contract manufacturing, laboratory, or related operations.
Demonstrated experience with quality risk management.
Technical knowledge and understanding of manufacturing processes or unit operations for sterile or large molecule products, coupled with the ability to collaborate with subject matter experts.
Leadership of cross-functional teams, investigations, or problem-solving situations.
Strong interpersonal skills including verbal and written communications, collaboration, teamwork within and across functions, conflict resolution. Proven ability to work effectively with diverse teams and individuals.
Demonstrated ability to manage projects and priorities, to meet deliverables and timelines.
Preferred Experience and Skills:
Sterile dosage drug product (vial, syringe, other) manufacturing and/or analytical testing.
A combination of experiences in quality assurance plus operations, laboratory, or related functional roles. Example functional roles include: quality operations, quality assurance, quality engineering, manufacturing, process engineering, product development, process development, materials management, supply chain management, quality control, analytical development, CMC regulatory affairs, equipment or facilities management.
Diverse experiences in a GMP environment including but not limited to batch production record development, review, or approval, ancillary batch related records, standard operating procedures, work instructions, raw materials, deviations, change control, corrective actions, preventive actions, out of specification results, cleaning, validation plans or protocols, equipment qualification, audits, electronic inventory systems, quality management systems.
Experience in manufacturing operations of sterile drug products, at pilot and/or commercial scale.
A combination of experiences in sterile product formulation, development, process development, manufacturing, technology transfer, scale-up, facilities, quality systems, and / or quality operations,
Advanced ability to identify, focus, and solve problems in a timely and efficient manner.
Experience with quality audits and EU regulatory inspections.
Experience or working knowledge of R&D or clinical supply areas and processes.
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:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
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.
Learn more about your rights, including under California, Colorado and other US State Acts
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”.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected US salary range:
$126,500.00 – $199,100.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.
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:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st – Day
Valid Driving License:
No
Hazardous Material(s):
No
Job Posting End Date:
02/26/2025
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:R335642
Title: Engineering and Quality Assurance Trainee
Company: 425 Manufacturing, Inc.
Location: Rockford, IL
