Quality Control Lead

Polysciences; Warrington Township (Bucks County); On-site; USD 88,000 - 106,000; Full time

Benefits offered by this job

Comprehensive Benefits

Medical Plans with Telemedicine, Rx, &

Vision

401(k) with company match

Paid Time Off

Paid Parental Leave

9 Paid Holidays

Job summary

Polysciences in Warrington, PA is seeking an Experienced Quality Control Lead to oversee in-process sampling, intermediate and finished products, and stability testing to support manufacturing and product release. You will mentor QC Analysts and coordinate testing with production, planning, and procurement.

The requirements include a Bachelor's Degree in Chemistry or related science, Six Sigma certification, and at least five years in an ISO 13485 or FDA GMP environment.

Qualifications

• Bachelor’s degree in Chemistry or related science required.
• Five+ years in ISO 13485 or FDA GMP environment.
• Six Sigma certification required.
• Proven leadership, coaching, mentoring, and team-building skills.

Responsibilities

• Lead QC team with hands-on training and mentoring.
• Coordinate sampling schedules for raw materials, in-process, intermediates and finished goods.
• Maintain 5S in QC areas and ensure safety and cleanliness.
• Review QC data and approve procedures and test methods.
• Escalate issues to QC Manager promptly.

Skills

Leadership

Mentoring

Training

Quality mindset

Communication

Education

Bachelor’s Degree in Chemistry or related science field

Six Sigma certification

Auditor (CQA) or related certification

Tools

GC-MS

GC-FID

LC-DAD

LC-MS

NMR

TGA

DSC

Microsoft Word

Microsoft Excel

Adobe Acrobat

Job description

Job DetailsLevel: ExperiencedJob Location: Warrington, PA 18976Position Type: Full TimeEducation Level: 4 Year DegreeSalary Range: $87,700.00 - $106,200.00 SalaryTravel Percentage: NoneJob Shift: M-F / 1st shiftJob Category: Medical Device Polysciences technical operations and scientific laboratories offer custom synthesis, contract manufacturing and packaging, and laboratory products. We are proud to offer a broad range of products and tailored solutions for the life sciences, bioprocessing, microparticles, medical devices, specialty chemical and eChem industries. We adhere to ISO13485:2016, FDA cGMP 21 CFR 820 regulations, and SOCMA’s ChemStewards® Management System. We believe the best scientific innovations are built through collaborations.

The Quality Control Lead is responsible for scheduling in-process samples, intermediate products, final products, and stability samples analytical analysis to support both product manufacturing and commercial product release needs. Serves as liaison between production, planning, business with the QC department for analytical activities needs. QC Lead is also responsible to mentor QC Analysts to ensure department’s compliance to the QC Laboratory Systems such as equipment maintenance, OOS Investigations, Inventory, Activity Logbooks, etc.

Essential Functions

• Provide leadership and guidance to the quality control team, including on-hands training, and mentoring.
• Coordinate work assignments for raw materials, in-process, intermediates and finished goods samples testing. Prioritize testing schedule to ensure efficient operation of the quality control department and adherence to KPIs.
• Foster a culture of accountability, collaboration, and continuous improvement within the team
• Leads other QC Analysts on laboratory inventory maintenance to ensure no impact to TAT. Assist on inventory sourcing along with Procurement Department when necessary. Escalates any potential issues to QC Manager in a timely manner.
• Independently performs equipment maintenance as well as equipment and software troubleshooting.
• Independently reviews of QC data, using both electronic systems and hard copy documentation as well as QC Orders Completion.
• Reports OOS results, compiles required information and independently completes laboratory investigation report
• Independently review, revise, and approve procedures and test methods
• Maintains a safe, clean, and organized environment (5S) for all QC areas. Ensures adherence to 5S audit schedule.
• Implement quality and continuous improvement initiatives, such as Six Sigma, Lean Manufacturing, or Total Quality Management principles.
• Engage cross-functional teams to implement best practices and foster a culture of continuous improvement
• When required, perform routine analytical analysis using the following equipment: volumetric glassware, balances, GC-MS, GC-FID, LC-DAD, LC-MS, NMR, TGA, DSC and others as required.
• Serves as QC Manager designee for approval, QC related investigations, protocols, reports, procedures and instructions.

Qualifications

• Bachelor’s Degree in Chemistry or related science field required.
• Six Sigma or related certification required.
• Auditor (CQA) or related certification preferred.
• At least five (5) years of experience working in an ISO 13485 or FDA GMP regulated environment required.
• Proven leadership abilities or training on coaching, mentoring, and team-building skills.
• Experience with quality control GMP documentation of testing results and assurance of laboratory data integrity and compliance required.
• Strong knowledge of analytical equipment, analytical methods, method validation and data analysis required. Knowledge of compendial methods (ie. USP, EP, ISO, ASTM) required.
• Knowledge on ICH guidelines preferred.

What We Offer

• Culture
• Great people
• Peer to Peer Recognition
• Broader, hands-on work experience
• Clean and Modern Equipment & Labs
• Fun company events
• Competitive Wages & Generous Year-end Bonus
• Comprehensive Benefits
• Medical Plans with Telemedicine, Rx, & Vision
• 2 Dental Plans
• Healthcare, Dependent care, & Commuter Flexible Spending Accounts
• 401(k) with company match
• Financial Health & Wellness w/1:1 Coaching & Rewards
• Basic & Supplemental Life Insurance
• Accident, Hospital Indemnity, & Critical Illness
• Paid Time Off
• Paid Parental Leave
• Short & Long-term Disability
• 9 Paid Holidays

Must have legal authorization to work in the US and will not require sponsorship.

Polysciences is an equal opportunity employer.

Drug-free workplace.

Tobacco-free work site.

Polysciences does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law.

All employment is decided on the basis of qualifications, merit and business need.

Equal access to programs, services, and employment is available to all persons.

Those applicants requiring reasonable accommodation to the application process and/or interview process should notify a representative of the Human Resources Department.

Find us here Poly 424

Qualifications Qualifications

Education Required: Bachelor's Degree

Preferred: Choose an item.

Certification(s): Specify preferred or required.

Bachelor’s Degree in Chemistry or related science field required.

Six Sigma or related certification required.

Auditor (CQA) or related certification preferred.

Computer Skills Required: Specify preferred or required.

Proficiency with Adobe, Microsoft Word and, Excel.

Other qualifications:

At least five (5) years of experience working in an ISO 13485 or FDA GMP regulated environment required.

Proven leadership abilities or training on coaching, mentoring, and team-building skills.

Experience with quality control GMP documentation of testing results and assurance of laboratory data integrity and compliance required.

Strong knowledge of analytical equipment, analytical methods, method validation and data analysis required.

Knowledge of compendial methods (ie. USP, EP, ISO, ASTM) required.

Knowledge on ICH guidelines preferred.

Immediate Work Environment

• X- ChemicalsUnprotected Height X-Fumes/Gases Persistent Noise
• X- PPE used: Lab Coat, Safety Shoes, and Safety Glasses

Work Activity: [must equal number of hours worked per day]

Stand: 3 Frequency: Intermittently Walk: 1 Frequency: Intermittently

Sit: 4 Frequency: Intermittently Drive: 0 Frequency: Choose an item.

Lift/Carry Demands

Frequency: Lift/Carry Equipment Provided:

0-10 lbs. 1-3 hours a day Reagents Bottles Carriers

11-25 lbs. Not Daily Rolling Cart

26-50 lbs. Rarely Gas Tank Hand Cart/Drum Lift Cart

51-75 lbs. Choose an item. Click or tap here to enter text.

76-100 lbs. Choose a item. Click or tap here to enter text.