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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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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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:

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Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe 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