Spclst, Quality Control

Job Description

Our Quality Assurance Group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Summary, Focus and Purpose

• The Quality Control Specialist requires knowledge and experience in the Quality Control discipline and solves a range of straightforward problems.

• Analyzes possible solutions using standard procedures.

• Builds knowledge of the company, processes, testing and customers.

• Receives a moderate level of guidance and direction and also proactively seeks advice/information from others when addressing serious business issues that may impact other functions.

• Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group while contributing and adding value to the achievement of team goals.

• Demonstrates a deep understanding of customer needs, requirements, and expectations.

• Continuously seeks new ways to improve services to customers and lean initiatives in the laboratory.

• Speaks up on tough issues and occasionally challenges the status quo. Expresses views and ideas at the right time while actively encouraging team members to make suggestions and share ideas.

• Works to develop new skills and abilities.

• Readily accepts performance feedback and incorporates this feedback into future performance.

• Assists other team members, including helping with developmental activities. Learns to use new problem-solving tools to surface and solve issues.

• Good organizational and time management skills.

• Assists in direction of plant wide or department objectives.

• Understands the fundamental business drivers for the company and uses this knowledge in own work and is proficient in multiple functional areas of the laboratory.

• Ability to interpret our Company Quality Policies and Guidelines for daily application.

• Understands and applies regulatory/compliance requirements, including GMP, NDA, and related regulations, and has the ability to interpret those regulations for implementation in the workplace.

• Possesses an expanded knowledge of theories, practices, and procedures in the Quality Laboratory, including the knowledge and understanding of pharmaceutical testing.

• Possesses strong technical writing capabilities and is able to compile more complex investigations, procedures, justifications, qualifications/validation protocols, etc.

• Possesses an advanced knowledge and ability to operate multiple instruments required to complete job responsibilities with the ability to generate data and reports from these instruments.

• Identifies and solves a range of problems in straightforward situations and analyzes possible solutions and assesses each using standard procedures.

• Ability to objectively respond to advanced requests for data and trending of data and proactively utilizes trending of data to improve the operation or drive change.

• Explains information and persuades others in straightforward situations.

• Develops presentations which includes those needed to influence the actions and decisions of others and presents to own work team or large groups with limited assistance of others.

• Makes decisions within guidelines and policies that impact own priorities and allocation of times to meet deadlines.

• Recommends scientifically sound corrective and preventive actions.

• Accountable for technical contribution to work or project team and may lead or manage a small project team.

Key Functions

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Completes a variety of testing to support release and stability requirements for a variety of products

• Supports all areas of the laboratory, cross-training and providing testing support in various work cells

• Provides training to other teammates and serves as subject matter experts

• Works with other company sites to ensure delivery schedules of samples to be tested are met

• Maintains compliance by following corporate policies/guidelines and local procedures

• Supports and leads continuous improvement projects with minimal assistance and works to ensure sustainability of implemented changes identified through lean six sigma tools/activities

• Identifies and implements changes focused on improving compliance performance in the laboratory

• Leads Tier I Activities and coordinates daily activities to ensure on-time, compliant testing is completed within their work cell and actively participates in Tier II and, as needed, Tier III

• Demonstrates in-depth understanding of product performance and testing methodology

• Able to train others on both and promotes an environment conducive with the 12 Inclusive Behaviors, actively promotes an inclusive culture and leads by example

• Identifies proactive measures to ensure right first time achievement

• Leads remediation of walk thru audits observations and works to ensure compliant operation of the laboratory to ensure successful outcomes of audits

• Works cross functionally to ensure proper prioritization/effective utilization of laboratory equipment

• Tests and interprets results for components, active pharmaceutical ingredients, water, microbial limit testing, finished pharmaceutical products, and stability samples

• Interprets compendial and internal monographs, NDAs, CFR and our Company Quality Standard

• Ensures laboratory compliance by adhering to cGMP, CFR, EU and other agency regulations

• Identifies improvement opportunities and both independently and as a facilitator of change, implements improvements

• Learns a variety of tools to drive continuous improvement (lean six sigma, human error prevention, etc.)

• Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents in the laboratory

• Maintains 5S organization throughout the laboratory and leads 5S activities to ensure compliance

• Provides guidance and coaching to new analysts within and outside his/her cell. Performs any other work as assigned by Manager

Education

• Bachelor of Arts or Science degree (preferably in Science or Engineering)

Experience | Skills | Knowledge

Required

• Two plus years demonstrated knowledge of continuous improvement principles

• Two plus years operating routine laboratory equipment including but not limited to: HPLC, Karl Fisher, Drug Dissolution, pH meter, etc.

• Knowledge of regulatory and cGMP principles

Preferred

• Utilizing Empower and LIMS

• Implementation of root cause analysis

• Knowledge of Tier process

• 5S principles

VETJOBS

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”.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

• 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:R339450