Recent Searches

You haven't searched anything yet.

3 Specialist, Laboratory Quality Assurance Jobs in West Point, PA

SET JOB ALERT
Details...
Merck
West Point, PA | Full Time
4 Months Ago
Eurofins USA PSS Insourcing Solutions
West Point, PA | Full Time
$90k-109k (estimate)
2 Weeks Ago
Eurofins
Eurofins
West Point, PA | Full Time
$99k-118k (estimate)
1 Month Ago
Specialist, Laboratory Quality Assurance
Merck West Point, PA
Full Time | Pharmaceutical 4 Months Ago
Save

sadSorry! This job is no longer available. Please explore similar jobs listed on the left.

Merck is Hiring a Specialist, Laboratory Quality Assurance Near West Point, PA

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.

The Specialist, Laboratory Quality Assurance (SLQA) provides direct Quality support to laboratory operations. With guidance from the Associate Director of Quality Assurance, the SLQA ensures quality and compliance of products tested by the functional area, adherence to Good Manufacturing and Documentation Practices, and represents quality on the shop floor and performs review of laboratory documentation/data for accuracy, completeness, and data integrity compliance. The incumbent may also assist in conducting investigation of deviations.

Additionally, the SLQA spends significant time on the shop floor in a team environment to provide quality coaching and guidance, to enable documentation to be completed right the first time, and to ensure compliance with cGMPs and regulatory requirements.


Responsibilities

  • Provides presence on the shop floor to support compliance and data integrity

  • Reviews laboratory documentation such as logbooks and worksheets to ensure accuracy and compliance with cGMPs, GLPs and company procedures and ensures completion of proper remediation of errors

  • Routine auditing of GMP practices, documentation, and data

  • Learns cGMPs, the analytical process, and our company quality systems, LIMS and electronic logbook, laboratory data, and batch record platforms

  • Becomes fully trained in relevant Standard Operating Procedures (SOPs) and competency-based activities

  • Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans

  • Actively participates in the Tier process and use this forum to make concerns visible and to partner with the functional area on resolution

  • Conducts review/approval of Qualification documents

  • Cross trains to support other functional quality areas including deviation management, documentation review, and qualification activities

  • Provides support to internal audits and regulatory inspections

  • Responsible for review/approval of Master Laboratory Worksheets prior to issuance

  • Conducts review/approval of new and updated SOPs and Controlled Job Aides

  • Fosters a customer service attitude within the functional area


Education Requirements

  • Bachelor degree, in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience


Experience and
Skills

Required

  • Minimum one to two years of relevant post-degree work in GMP Manufacturing or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting

  • Leadership skills connected with strategic and effective verbal and written communication skills

  • Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area

  • Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment

  • Titers may be required

Preferred

  • Quality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documents

  • Demonstrated analytical aptitude, critical thinking skills and problem-solving skills

  • Demonstrated ability to upskill/coach others

  • Familiarity with GMP documentation review and/or shop floor auditing

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

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.

For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.


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.

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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

:

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:

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1


Requisition ID:
R213901

Job Summary

JOB TYPE

Full Time

INDUSTRY

Pharmaceutical

POST DATE

12/04/2022

EXPIRATION DATE

12/06/2022

WEBSITE

merck.com

HEADQUARTERS

KENILWORTH, NJ

SIZE

>50,000

FOUNDED

1891

TYPE

Public

CEO

KENNETH C FRAZIE

REVENUE

$10B - $50B

INDUSTRY

Pharmaceutical

Related Companies
About Merck

Merck is a New Jersey-based global pharma company that develops and manufactures prescription medicines, novel vaccines, biologic therapies and animal health products.

Show more

Merck
Full Time
$67k-91k (estimate)
1 Month Ago
Merck
Full Time
$50k-63k (estimate)
1 Month Ago