What are the responsibilities and job description for the Quality Specialist position at Sterling Pharma Solutions?
Location: Germantown, Wisconsin, US
Department: Quality
Reference: VN1350
The Quality Specialist is accountable for driving results in a fast-paced environment by effectively performing activities of some variety and complexity to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing release documents and data, conducting basic floor audits, consulting on quality and compliance issues, and performing quality and compliance training as needed. The Quality Specialist assists with the development of SOPs or other quality documents as needed. The position requires execution of the Sterling Values and non-negotiables, as well as expertise in functional competencies included in this position profile
Shift: This position works a Tuesday–Saturday day shift schedule. Employees in this shift are eligible for an additional shift incentive on all hours worked.
Your Responsibilities
We offer a competitive compensation and benefits package including medical/dental/vision/life insurance, paid time off, bonus program, 401k match, tuition reimbursement, 24/7 employee assistance program, flexible work hours, and the opportunity for career training and development.
Location
This position is located in Germantown, WI, a vibrant city northwest of Milwaukee in Southeast Wisconsin. A great place to live, work and raise a family, Southeast Wisconsin offers a variety of activities and diverse cultural scene.
Diversity and Inclusion
Sterling values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.
Why consider Sterling?
Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.
We are a fast growing, dynamic business with facilities in the UK, Europe and the US, where we employ more than 1300 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.
Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.
Sterling Pharma Solutions is an equal opportunity employer.
Be caring. Be transparent . Be willing. Be reliable.
Apply now
Department: Quality
Reference: VN1350
The Quality Specialist is accountable for driving results in a fast-paced environment by effectively performing activities of some variety and complexity to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing release documents and data, conducting basic floor audits, consulting on quality and compliance issues, and performing quality and compliance training as needed. The Quality Specialist assists with the development of SOPs or other quality documents as needed. The position requires execution of the Sterling Values and non-negotiables, as well as expertise in functional competencies included in this position profile
Shift: This position works a Tuesday–Saturday day shift schedule. Employees in this shift are eligible for an additional shift incentive on all hours worked.
Your Responsibilities
- Performs quality review and approval of batch specific documents, cleaning documents, reference standard and all types of data.
- Performs quality release of intermediates, active pharmaceutical ingredients (APIs), and raw materials.
- Drafts and reviews Certificates of Analysis (CoA) and Certificates of Conformance (CoC).
- Performs area clearance and release of equipment and facilities for GMP use as required.
- Assists with development/writing of SOPs or other quality documents and/or reports as needed.
- Provide training in quality and compliance topics in areas of expertise.
- Maintains accurate files and records.
- Bachelor’s degree in chemistry, Biology, or related field with 3 years GMP related experience, or
- Master’s degree in related field with 1 years related experience, or equivalent educational and work experience.
We offer a competitive compensation and benefits package including medical/dental/vision/life insurance, paid time off, bonus program, 401k match, tuition reimbursement, 24/7 employee assistance program, flexible work hours, and the opportunity for career training and development.
Location
This position is located in Germantown, WI, a vibrant city northwest of Milwaukee in Southeast Wisconsin. A great place to live, work and raise a family, Southeast Wisconsin offers a variety of activities and diverse cultural scene.
Diversity and Inclusion
Sterling values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.
Why consider Sterling?
Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.
We are a fast growing, dynamic business with facilities in the UK, Europe and the US, where we employ more than 1300 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.
Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.
Sterling Pharma Solutions is an equal opportunity employer.
Be caring. Be transparent . Be willing. Be reliable.
Apply now