Job Description

Our Quality Control Associate Specialist are responsible for testing of product to ensure compliance with regulatory requirements. We work in the QC Laboratory with a “Safety First, Quality Always” mindset striving for continuous improvement.

Primary Responsibilities

Employee must show ability to perform routine assignments and develops competence by performing structured work assignments

Ability to follow analytical standards, lab procedures and work instructions to perform routine testing

Requires knowledge and exposure to fundamental laboratory instrumentation, theories, principles, and concepts

Receives instruction, guidance, and direction from others and also seeks advice/information from others when addressing serious business issues that may impact other functions

Builds and promotes the Team’s effectiveness through actions that demonstrate respect and appreciation for diverse perspectives

Demonstrates understanding of customer needs, requirements, and expectations

Right the First Time execution

Speaks up on issues and 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

Applies general knowledge of company business developed through education and past experience

Ability to interpret our Company Quality Policies, Guidelines and Testing Procedures for daily application

Understands and applies regulatory/compliance requirements, including Good Documentation Practices (GDP), Non-Disclosure Agreement (NDA), and related regulations, and has the ability to interpret those regulations for implementation in the workplace

Possesses a basic knowledge of theories, practices, and procedures in the Quality Control discipline, including the knowledge and understanding of pharmaceutical testing

Active with developing technical writing capabilities and is able to compile straightforward investigations and procedures, and recommend scientifically sound corrective actions

Possesses a basic knowledge and ability to operate lab instrumentation required to complete job responsibilities

Ability to independently respond to basic requests for data and trending of data

Communicates information and asks questions to check for understanding

Develops small scale presentations and presents to own work Team or small groups with the assistance of others

Limited decision-making authority and works within technical guidelines/direction to achieve objectives and meet deadlines

Accountable for technical contribution to work or project Team

Education Requirements

Bachelor's degree in Science, Chemistry, Biology or related discipline

Required Experience and Skills

Proficient with Microsoft Word and Excel

Ability to work with others on a team

Accountability for own actions, and ability to prioritize

Knowledge of regulatory and current GMP principles

Preferred Experience and Skills

Operating laboratory equipment:  HPLC, dissolution apparatus, KF, etc.

Utilizing Empower | Labware/LIMS

Execution of root cause analysis

Background in technical writing including but not limited to: updating of standard operating procedures and writing quality notifications

Knowledge of Tier processes

Executing 5S principles

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.

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VETJOBS

Current Employees apply HERE

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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):

Yes

Job Posting End Date:

11/20/2024

*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:R320021