Quality Control Analyst I (Manufacturing)

Who We Are

Ott Scientific

The Ott Scientific family of companies comprises Polysciences, Bangs Laboratories, and Ethos Biosciences. Together, we bring the whole of our experience with best-in-class facilities and scientific, technical, analytical, and manufacturing capabilities to serve customers around the globe. We deliver highly specialized products and services that support scientific discoveries and innovations.

Polysciences

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 device, 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.

We're hiring a Quality Control Analyst in our Quality Control group who will use analytical equipment, analytical methods, and perform data analysis.  Will test using GC, HPLC, LC/MS, KF, FTIR, UV-Vis, Viscometers, and Atomic Absorption, NMR, etc.

RESPONSIBILITES:

• Experience with Quality GMP documentation (hard copy and electronic) of testing results and assurance of laboratory data integrity and compliance.
• Perform Quality Control testing of raw materials, in-process and finished product samples per approved internal and customer specifications following approved test methods.
• Aid in maintaining quick turnaround time of incoming material release. Assist in sampling of raw materials upon receipt, when needed. 
• Experience with electronic QC data entry, preferably using an ERP system.
• Experience with USP/EP interpretation and testing preferred.
• Support QC audit readiness with understanding of FDA and ISO 13485:2016 regulations and requirements.
• Support on-time performance in the QC lab against the Production and laboratory schedules.
• Assist with maintenance and troubleshooting of QC lab equipment to minimize downtime.
• Assist with OOS/LIR investigations.
• Maintain a safe, clean and organized environment (5S) for all QC areas.
• Employ sound and compliant laboratory techniques and logic per industry standards (e.g., FDA, USP/NF, EP, ICH) and internal and customer requirements.
• Providing training to other analysts to perform laboratory procedures and assays as needed.
• Keep Supervisor informed of any Quality related issues that arise in the laboratory.

EDUCATION AND SKILLS REQUIRED:

• Bachelor's degree in chemistry, chemical engineering or a similar field with at least 1 + years of quality control testing experience required.
• Experience working in an ISO 13485:2016 or FDA regulated environment required.
• Experience working in a fast-paced lab environment preferred.
• Knowledge of analytical equipment, analytical methods, and data analysis required.
• QC equipment experience: GC, HPLC, KF, FTIR, UV-Vis, Viscometers, required.
• QC equipment experience: LC/MS, Atomic Absorption, and NMR preferred.
• Excellent communication and organizational skills.
• Proficiency with Microsoft Word and Excel.
• Ability to multitask and support multiple business projects at a time.

We've got great employees who work hard but like to have a bit of fun. We are serious about business and enthusiastic about our work environment. Bingo, lunch-time cookouts, fall picnic, holiday party, theme days, etc.

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

4 Medical PPO 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

Basic & Supplemental Life Insurance

Accident, Hospital Indemnity, & Critical Illness

Paid Time Off

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

Education Required: Bachelor's Degree                                                 Preferred: Bachelor's Degree                     

Certification(s): Specify preferred or required.

Computer Skills Required: Specify preferred or required.

Experience with Open Lab, Chem Station and/or Empower analytical software preferred.

Proficiency with Adobe, Microsoft Word and Excel required.

Other qualifications:

• Bachelor's degree in chemistry or related science field required.
• At least one (1) year of experience working in an ISO 13485 or FDA GMP regulated environment preferred.
• Bachelor's degree in chemistry or related science field required. At least one (1) year of experience working in an ISO 13485 or FDA GMP regulated environment preferred.
• Experience with quality control GMP documentation of analytical testing results and assurance of laboratory data integrity and compliance preferred.
• Knowledge of analytical equipment, analytical methods, and data analysis required.

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

Immediate Work Environment:

X-Chemicals                    Unprotected 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:     4             Frequency:  Intermittently                           Walk:     1             Frequency:  Intermittently          

Sit:          3             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.              Never                     Click or tap here to enter text.

76-100 lbs.            Never                     Click or tap here to enter text.

Salary Minimum: 60000Salary Maximum: 75000