Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies.
Testing may include but not limited to samples from drug substance and drug product manufacturing, stability and various protocol studies using approved test methods or test methods derived from QC technical protocols.
May assist in sampling activities.
This position is expected to maintain operational and GMP readiness of the QC areas as well as maintain critical reagent inventory such as antibodies and cell banks at business appropriate quantities.
In addition, the individual may participate in more complex projects, operational excellence initiatives, and various quality systems with general supervision.
Discretion/Latitude: Works under general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy
Impact: Exerts some influence on the overall objectives and long-range goals of the organization. Erroneous decisions or failure to achieve objectives would normally have a serious effect upon the administration of the organization.
Specific Biochemistry Focus Areas: Product Testing: Area focuses on techniques such as SDS-PAGE Silver, QPCR, Potency, Kinetics assay, Enzyme Activity, pH, Osmo, A280 etc., in order to support in-process, release and stability testing.
Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation.
Introduction of new equipment and technology to improve sustainability and compliance is expected.
Additionally, the role provides support for Quality projects and implementation of operational excellence initiatives.
Responsibilities: Job Function and Description
Receives assignments in the form of objectives and establishes goals to meet objectives. Work is reviewed and measured based on meeting objectives and schedules. Establishes and recommends changes to policies which effect subordinate organizations.
% of Time Job Function and description:
40-50% Testing execution, participate in training analysts, trouble shooting of methods
20-30%: QC operations support which entails data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab house keeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records)
10-20% Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support.
Education and Experience Requirements
Include educational requirements or equivalency, required years and type(s) or experience, and necessary licenses or certificates. Specify which are required and which are preferred. For UK, please do not use years of experience due to UK Legislation Typically requires a bachelor’s degree and a minimum of 5+ years of related experience. (science related degree is preferred)
Additional Specific Experience:
Excellent communication, interpersonal and organizational skills.
Ability to work well both independently and in a team environment.
Ability to prioritize work and multitask.
Previous experience in a GMP QC role is preferred
Key Skills, Abilities, and Competencies
Describe critical skill and abilities needed to successfully perform the job, which should be representative of the knowledge, skills, and abilities required. Reasonable accommodations may be
made to enable individuals with disabilities to perform the essential functions.
Knowledge: Complete understanding and application principles, concepts, practices and standards. Full knowledge of industry practices. Position requires critical thinking.
Key Skills: MS Office, LIMS, SAP, Trackwise , compliance and strong science understanding
Complexity and Problem Solving
Describe the decisions made by the incumbents on a regular basis. Include decisions within the
Incumbent’s authority to make as well as those decisions that must be referred to a higher level.
Develop solutions to a variety of complex problems. May refer to established precedents and policies. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgement in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.
Internal and External Contacts
List contacts this job advises, consults, or coordinates with on a regular basis. Describe to whom the job is accountable. Indicate each Contact category (Internal, Vendor, Customer, or Other) and provide examples.
Contacts are primarily with immediate supervisor, and other personnel in the section or group.
Contacts external to QC may include: Analytical Development, R&D, Quality Assurance and other Quality functions, Regulatory , Manufacturing, Facilities and Engineering
Other Job Requirements
List any other job requirements, including travel, physical abilities required, etc.
Limited to no travel expected. Travel between sites is required.
The following physical abilities are required in order to fulfill the job duties:
Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)
Ability to work around chemicals (if working around the laboratories)
Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases
Ability to walk and stand for periods of time
Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $53.00/hr.
