QC Sr. Specialist
Spectraforce
Durham, North Carolina
8 days ago
Job Description
Job Title: QC Sr. Specialist
Location: Durham, NC 27713
Duration: 11 Months
Summary:
The Specialist, Quality Control, assists and supports the organization with compliance and ongoing preparation, testing and monitoring of conformance to established quality processes and standards for manufacturing and production.
Responsibilities:
• Act a coordinator for Quality activities including site to site method transfer and internal project coordination.
• Assists in the evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
• Reviews data obtained for compliance to specifications and reports abnormalities. Performs trend analysis of methods /environmental data / assay controls & standards and draws conclusions.
• Capable of delivering to assigned work schedule with attention to detail and accuracy.
• Support department risk assessments and participates in audit walk-throughs.
• Participates in the preparation of investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT/OOE and Investigation.
• Authors new/revise Standard Operating Procedures, Protocols / Summary Reports /Analytical Master Plans for QC.
• Oversees special projects on analytical and instrument problem solving. May develop testing and analysis methods and procedures in accordance with established guidelines.
• Supports training of departmental personnel in appropriate technique and related topics.
• Other related job duties as assigned.
Requirements:
• Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 8 years’ experience in GMP environment or 7 years’ at GTx.
• Familiarity with cGMP release and characterization testing using techniques including but not limited to cell-based methods (potency, AA), PCR (ddPCR, qPCR), Immunoassays (ELISA), chromatography (HPLC-UV), AUC, compendial assays (Bioburden, pH), electrophoresis (CE, Western Blot), cell culturing, and Microbiology/Release sampling (EM, Compressed Gas).
• Excellent interpersonal, verbal and written communication skills with strong technical writing experience required. Previous investigation experience a plus.
• Proven ability to work effectively in a team environment. Collaborates cross functionally with other departments to achieve site goals.
• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.?
• Exercises judgment within defined procedures and practices to determine appropriate action including critically thinking, troubleshooting and problem-solving skills.
• Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of core duties.
About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
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: $30.00/hr.
Location: Durham, NC 27713
Duration: 11 Months
Summary:
The Specialist, Quality Control, assists and supports the organization with compliance and ongoing preparation, testing and monitoring of conformance to established quality processes and standards for manufacturing and production.
Responsibilities:
• Act a coordinator for Quality activities including site to site method transfer and internal project coordination.
• Assists in the evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
• Reviews data obtained for compliance to specifications and reports abnormalities. Performs trend analysis of methods /environmental data / assay controls & standards and draws conclusions.
• Capable of delivering to assigned work schedule with attention to detail and accuracy.
• Support department risk assessments and participates in audit walk-throughs.
• Participates in the preparation of investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT/OOE and Investigation.
• Authors new/revise Standard Operating Procedures, Protocols / Summary Reports /Analytical Master Plans for QC.
• Oversees special projects on analytical and instrument problem solving. May develop testing and analysis methods and procedures in accordance with established guidelines.
• Supports training of departmental personnel in appropriate technique and related topics.
• Other related job duties as assigned.
Requirements:
• Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 8 years’ experience in GMP environment or 7 years’ at GTx.
• Familiarity with cGMP release and characterization testing using techniques including but not limited to cell-based methods (potency, AA), PCR (ddPCR, qPCR), Immunoassays (ELISA), chromatography (HPLC-UV), AUC, compendial assays (Bioburden, pH), electrophoresis (CE, Western Blot), cell culturing, and Microbiology/Release sampling (EM, Compressed Gas).
• Excellent interpersonal, verbal and written communication skills with strong technical writing experience required. Previous investigation experience a plus.
• Proven ability to work effectively in a team environment. Collaborates cross functionally with other departments to achieve site goals.
• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.?
• Exercises judgment within defined procedures and practices to determine appropriate action including critically thinking, troubleshooting and problem-solving skills.
• Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of core duties.
About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
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: $30.00/hr.